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Learn more: PMC Disclaimer | PMC Copyright Notice BMJ Open . 2026 Jan 8;16(1):e114522. doi: 10.1136/bmjopen-2025-114522 Search in PMC Search in PubMed View in NLM Catalog Add to search Integrating the Common Elements Treatment Approach and motivational interviewing to improve HIV pre-exposure prophylaxis engagement among women who use drugs in Tanzania: protocol for a pilot randomised controlled trial Haneefa Saleem Haneefa Saleem 1 Department of International Health, Johns Hopkins University, Baltimore, Maryland, USA Find articles by Haneefa Saleem 1, ✉ , Kaitlyn Atkins Kaitlyn Atkins 1 Department of International Health, Johns Hopkins University, Baltimore, Maryland, USA Find articles by Kaitlyn Atkins 1 , Stephanie Skavenski Stephanie Skavenski 2 Department of Mental Health, Johns Hopkins University, Baltimore, Maryland, USA Find articles by Stephanie Skavenski 2 , Bareng Aletta Nonyane Bareng Aletta Nonyane 1 Department of International Health, Johns Hopkins University, Baltimore, Maryland, USA Find articles by Bareng Aletta Nonyane 1 , Frank Chitamwebwa Frank Chitamwebwa 3 Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania, United Republic of Find articles by Frank Chitamwebwa 3 , Sifaely Mtaita Sifaely Mtaita 3 Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania, United Republic of Find articles by Sifaely Mtaita 3 , David Mwansa David Mwansa 2 Department of Mental Health, Johns Hopkins University, Baltimore, Maryland, USA Find articles by David Mwansa 2 , Adela Luswetula Adela Luswetula 1 Department of International Health, Johns Hopkins University, Baltimore, Maryland, USA Find articles by Adela Luswetula 1 , Laura K Murray Laura K Murray 2 Department of Mental Health, Johns Hopkins University, Baltimore, Maryland, USA Find articles by Laura K Murray 2 , Samuel Likindikoki Samuel Likindikoki 3 Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania, United Republic of Find articles by Samuel Likindikoki 3 Author information Article notes Copyright and License information 1 Department of International Health, Johns Hopkins University, Baltimore, Maryland, USA 2 Department of Mental Health, Johns Hopkins University, Baltimore, Maryland, USA 3 Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania, United Republic of ✉ Dr Haneefa Saleem; [email protected] None declared. Supplemental material: Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. Received 2025 Nov 26; Accepted 2025 Dec 18; Collection date 2026. Copyright © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/ . PMC Copyright notice PMCID: PMC13059894 PMID: 41506761 Abstract Introduction Women who use drugs in Tanzania face a disproportionately high burden of HIV and mental health disorders. Despite the availability of pre-exposure prophylaxis (PrEP), uptake remains low, highlighting the need for integrated, scalable interventions that address co-occurring substance use and mental health challenges. Motivational interviewing (MI) and cognitive-behavioural approaches, such as the Common Elements Treatment Approach (CETA), show promise for enhancing HIV prevention outcomes in this population. This study presents the protocol for a pilot feasibility trial assessing the acceptability, feasibility and preliminary efficacy of MI for PrEP (MI-PrEP) and a combined CETA and MI-PrEP intervention (CETA + MI-PrEP) to improve PrEP engagement among women who use drugs in Tanzania. Methods and analysis This individually randomised, parallel-group pilot trial will be conducted in Dar es Salaam, Tanzania, guided by the situated Information, Motivation and Behavioral Skills model. Eligible participants are adult women who use heroin, report recent drug-related or sex-related HIV risk behaviours, are HIV-negative and exhibit symptoms of depression, anxiety or post-traumatic stress disorder. Participants are randomised to one of three arms: MI-PrEP, CETA + MI-PrEP or enhanced treatment as usual. Interventions are delivered face-to-face by trained counsellors. Feasibility and acceptability will be assessed using recruitment and retention data, surveys and qualitative interviews. Preliminary effects will be measured for PrEP initiation, symptoms of common mental disorders and substance use. Ethics and dissemination Ethical approval has been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board (25580), the Muhimbili University of Health and Allied Sciences Ethics Review Committee (MUHAS-REC-12-2023-1994) and the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4830). Results will be disseminated through ClinicalTrials.gov, peer-reviewed publications, conferences, presentations and research briefings to community stakeholders. Trial registration ClinicalTrials.gov ID: NCT06835751 . Initially registered 14 February 2025, https://clinicaltrials.gov/study/NCT06835751 , last updated 5 December 2025. Keywords: HIV & AIDS, MENTAL HEALTH, Randomized Controlled Trial, Africa South of the Sahara, Substance misuse STRENGTHS AND LIMITATIONS OF THIS STUDY. The trial targets the intersecting burdens of substance use, mental health conditions and HIV risk among women who use drugs, using tailored motivational interviewing for pre-exposure prophylaxis (MI-PrEP) and Common Elements Treatment Approach (CETA) + MI-PrEP interventions designed for this population. Interventions are low-cost, adaptable and deliverable by paraprofessionals, including peers, enhancing scalability and feasibility in community settings. The flexible, transdiagnostic CETA + MI-PrEP model offers potential applicability to other highly vulnerable groups with co-occurring mental health and substance use challenges. Recruitment through community outreach workers may limit representation of women who use drugs outside known networks or who engage in more hidden drug use. There is a risk of attrition over the course of the study. Introduction Women who use drugs, specifically heroin, in Tanzania face a disproportionate burden of HIV, with prevalence rate estimates up to eight times higher than the general population 1 and significantly higher than men who use drugs. 2 3 High levels of engagement in sex work, economic dependency on male partners, housing instability and experiences of physical and sexual violence contribute to the heightened vulnerability to HIV experienced by women who use drugs in Tanzania. 4 , 6 The relationship between sex work, drug use and the management of withdrawal pains can reduce women’s ability to practise HIV preventive behaviours, such as condom negotiation, and place them in dangerous situations that expose them to violence and further increase their risk of HIV. 4 7 8 Pre-exposure prophylaxis for HIV (PrEP) is a highly effective HIV prevention tool. While oral PrEP has been available in Tanzania since 2017 9 and shows high acceptability among key populations, actual uptake remains strikingly low, creating a critical gap between availability and use. 10 Increasing PrEP use and adherence among key populations is critical to reducing HIV incidence and ending the HIV epidemic in Tanzania. The high prevalence of mental disorders among people who use drugs, women especially, represents a significant and often overlooked barrier to PrEP uptake and adherence. 11 , 13 Mental disorders can compound HIV risks and adversely affect HIV prevention, including PrEP engagement, by driving maladaptive coping behaviours, such as increased drug consumption or avoidance of HIV services. 14 Co-occurring drug use and mental disorders create barriers to PrEP engagement. 15 , 17 Common mental disorders, such as depression and anxiety, have been associated with low PrEP use and adherence. 16 18 Untreated mental disorders have been shown to reduce motivation for PrEP adherence for some 15 , 1719 and increase motivation for others. 19 20 Stigma can have profound effects on mental health, including increased rates of depression, anxiety and harmful substance use. 21 , 23 Stigma, particularly internalised stigma, can contribute to social isolation and limit social support. 24 A lack of a strong social support network may compromise individuals’ capacity to initiate and adhere to PrEP and sustain other HIV prevention practices. 25 26 In Tanzania, symptoms of depression and anxiety are disproportionately high among women who use drugs. 21 27 Without coordinated HIV services that address both mental health and substance use, women who use drugs may find it difficult to maintain the consistent PrEP engagement needed for protection, thereby reinforcing their HIV vulnerability. Strategies that take a syndemic approach, addressing the intersecting effects of substance use and mental health on HIV prevention, are critical for this highly vulnerable yet understudied population of women who use drugs. Motivational interviewing (MI) and cognitive-behavioural therapy (CBT) are evidence-based interventions with demonstrated effectiveness in addressing substance use and mental disorders while improving HIV service engagement, making them promising interventions for potentially increasing PrEP engagement among women who use drugs. Limited access to mental health specialists, particularly in low-resource settings, points to the need for approaches that address multiple behavioural and mental health problems that can be task-shifted to lay and paraprofessionals. Both globally and in Tanzania, MI and CBT have been successfully delivered by trained paraprofessionals, that is, lay workers, to provide treatment for a range of health conditions, including substance use and common mental disorders. 28 , 32 MI is a collaborative counselling style in which practitioners work with clients to strengthen their motivation and capacity to change unhealthy behaviours. 33 34 Grounded in the transtheoretical model of change, MI involves four key processes: building a collaborative relationship, clarifying and centring the client’s goals, drawing out the client’s motivations and addressing ambivalence and developing an action plan for change. 34 35 MI sessions can occur in clinical or community settings and can be delivered by clinicians or trained paraprofessionals. 36 Originally developed in addiction treatment, MI has since been used globally to promote positive health behaviours. 37 There is a growing body of evidence that MI-based interventions can improve PrEP action, initiation and adherence. 38 , 42 CBT is a well-established, structured evidence-based form of psychotherapy that helps people identify and modify unhelpful thoughts, emotions and behaviours. It has a wide range of applications across mental health and behavioural conditions, from common mental disorders to substance use and addictive behaviours. The Common Elements Treatment Approach (CETA) is a transdiagnostic psychotherapy intervention rooted in CBT developed for use in low- and middle-income countries, particularly those with limited access to mental health resources, for delivery by lay counsellors with no or little previous mental health training. 43 Transdiagnostic interventions, such as CETA, are particularly promising because they include a set of common practice elements that can be delivered in different combinations, depending on individual symptom presentation, to simultaneously address behavioural and mental health problems. 44 CETA offers a treatment alternative that is not reliant on diagnoses of specific mental disorders and allows for flexible adaptation to meet individual needs. 43 CETA has been shown to improve comorbid mental health symptoms and HIV treatment retention among people living with HIV. 45 46 In this paper, we describe the protocol for a pilot feasibility trial that assesses the feasibility and preliminary effects of MI to improve PrEP engagement (MI-PrEP) and a combined CETA and MI-PrEP intervention to improve PrEP outcomes among women who use drugs in Tanzania by addressing comorbid mental health conditions. Methods and analysis Trial design and overview This feasibility study is an individually randomised controlled parallel group pilot trial in Dar es Salaam, Tanzania, conceptually guided by a situated Information, Motivation, Behavioral Skills model. 47 48 Study participants are adult women who self-report drug-related or sex-related HIV risk behaviours and heroin use in the past 6 months, who test negative for HIV and who meet criteria for depression, anxiety or post-traumatic stress disorder (PTSD) symptoms. Participants are randomised to receive MI-PrEP alone, the combined CETA + MI-PrEP intervention or enhanced treatment as usual (TAU). Recruited women are screened for eligibility, which includes a rapid HIV test. All trial participants complete a baseline assessment survey at enrolment, administered face-to-face by a member of the study team. Following the baseline assessment, participants receive the intervention to which they were randomised. Both interventions (MI-PrEP and CETA + MI-PrEP) are delivered through face-to-face interactions by trained counsellors. All participants receive information and resources on HIV prevention, PrEP, substance use disorder treatment and mental health services. Participants are assessed at enrolment and 6 months post enrolment. A subsample of pilot trial participants will complete a follow-up qualitative, indepth interview approximately 1 month after completing their assigned intervention sessions. Intervention counsellors will also complete a follow-up qualitative, indepth interview at the end of the trial period. The study flow diagram is illustrated in figure 1 . Figure 1. Consolidated Standards of Reporting Trials flow diagram of participant recruitment and participation. Women will be assessed for eligibility through a screening survey and HIV testing. After providing informed written consent and completing the baseline assessment survey, eligible women will be randomised to one of three study arms using a 1:1:2 allocation: Motivational Interviewing for pre-exposure prophylaxis (MI PrEP), combined Common Elements Treatment Approach (CETA) and MI PrEP and treatment as usual. Follow-up assessments will take place 1 month post intervention completion (for a subsample of 30 participants in the two intervention arms) and 6 months post enrolment for all participants. Open in a new tab Study setting This study is set in Dar es Salaam, Tanzania. The HIV epidemic in Tanzania is characterised by heterogeneity across gender, geographical location and age. According to the Tanzania HIV Impact Survey 2022–2023, annual HIV incidence among individuals aged 15 years and older was 0.18%, corresponding to approximately 60 000 new infections per year, with women experiencing roughly twice the incidence of men. 49 Overall adult HIV prevalence was 4.4%, with a higher burden among women (5.6%) than men (3%). Prevalence peaked among women aged 45–49 years at 13% and men aged 50–54 years at 8.4%. HIV prevalence varied widely regionally, ranging from 1.7% in Kigoma to 12.7% in Njombe, with Dar es Salaam reporting prevalence at 4.2%, underscoring its continued importance as an epicentre for HIV prevention efforts, particularly among key populations. Key and vulnerable populations, including people who use drugs, female sex workers and men who have sex with men, have significantly higher HIV prevalence and incidence compared with the general population. 2 50 51 In 2017, the Ministry of Health, Community Development, Gender, Elderly and Children integrated oral PrEP into existing service delivery models for key and vulnerable populations as part of a demonstration project. PrEP is now a central component of the national HIV prevention strategy with a national focus on differentiated, community-based delivery models to reach those at greatest risk. 52 53 PrEP services are primarily delivered through HIV clinics, stand-alone HIV testing centres and increasingly through mobile and community-based clinics supported by implementing partners. Service delivery relies on clinicians and nurses, with community health workers and peer outreach workers providing support to generate demand, expand access and improve retention particularly among key and vulnerable populations. 9 Despite PrEP’s central role in the national HIV prevention strategy, there remains low community awareness of PrEP, with only 8.8% of adults in urban areas versus 4.9% in rural areas reporting awareness of PrEP. 53 Patient and public involvement For this study, we established a community advisory board (CAB) and a study advisory board (SAB). The CAB is composed of eight women with lived experience of drug use and advises on ethical and recruitment issues and study implementation to ensure that research processes are respectful of and acceptable to the primary beneficiaries. We also maintain a SAB that is composed of eight representatives from academia, government agencies, civil society and women with lived experience of drug use. The SAB advises on study design, study implementation, intervention adaptations, data analysis and interpretation. The CAB and SAB meet biannually. Eligibility criteria Inclusion criteria : Inclusion criteria for pilot trial participants are—(1) female sex, (2) 18 years or older, (3) non-reactive or negative HIV test result, (4) self-reported drug-related or sex-related HIV risk behaviours in the past 6 months, (5) participant reports hazardous or harmful heroin use in the past 6 months and (6) participant meets criteria for at least one of the following co-occurring mental health conditions: symptoms of depression (Patient Health Questionnaire-9 (PHQ-9) score ≥9), 54 anxiety (Generalized Anxiety Disorder Scale-7 (GAD-7) score ≥10) 55 and/or PTSD (Harvard Trauma Questionnaire (HTQ) score ≥40). 56 Exclusion criteria : Exclusion criteria for trial participants are—(1) reactive or positive HIV test result, (2) currently taking PrEP, (3) actively suicidal, homicidal or psychotic and needing immediate hospitalisation based on safety assessments and/or (4) unable to provide informed consent. Recruitment and retention procedures Recruitment is conducted in collaboration with community outreach workers at community-based organisations in Dar es Salaam providing harm reduction services for people who use drugs and with community outreach workers at medically-assisted therapy (MAT) clinics offering methadone treatment in Dar es Salaam. Outreach workers identify women who might be eligible and interested in participating in the study and connect them to the study team. Women who meet the eligibility criteria are tested for HIV at a partnering government HIV testing site, and if HIV-negative, proceed to the full trial consent. The study team employs a multipronged and flexible approach to recruitment and retention. Recruitment and retention strategies are outlined in table 1 . Table 1. Recruitment and retention strategies. Strategy Description Recruitment Partnerships with CBOs and MAT clinics Collaborate with community-based organisations and MAT clinics to identify and refer eligible women who use drugs. Community outreach Engage outreach workers with lived experience to reach potential participants through peer networks and community visits. Flexible scheduling Offer screening and enrolment visits during late afternoons or evenings to accommodate participants’ schedules. Retention Multiple contact methods Collect detailed contact information at enrolment, including alternate contacts, to facilitate follow-up. Visit reminders and follow-up Send appointment reminders and follow-up promptly on missed visits via participants’ preferred communication methods. Community outreach worker engagement Engage outreach workers to maintain participant contact, support retention and assist with mapping of hotspots and sex-work hubs. Outreach workers conduct flexible site visits, including evening or ‘moonlighting’ hours, based on client availability. Flexible visit times Schedule intervention and assessment visits outside normal hours, including evenings, as needed. Safety and support protocols Implement established safety and referral procedures to ensure participant well-being throughout the trial. Open in a new tab CBOs, community-based organisations; MAT, medically-assisted therapy. Screening and enrolment procedures Study staff explain the study, answer questions and review components of the screening consent. Women who are interested in participating provide informed consent to be screened for study eligibility using the eligibility screening questionnaire. The screening survey questionnaire is administered by a member of the study team and screening data are captured electronically. Those who meet study eligibility based on screening survey responses are then tested for HIV at a partnering government HIV testing site. A member of the study confirms the HIV-negative test results. Eligible women complete the full consent process for the pilot trial. Study staff read the consent form to the participant, answer questions and review the components of the trial consent form (see online supplemental material 1 ). Women interested in participating in the trial then provide informed consent and proceed to enrolment and the baseline assessment survey, which is administered via a face-to-face interview with a study team member and recorded electronically in Research Electronic Data Capture hosted by the Muhimbili University of Health and Allied Sciences. 57 58 Randomisation After completing the baseline assessment survey, participants are randomised to one of three study arms: (1) MI-PrEP only, (2) CETA + MI-PrEP or (3) enhanced TAU. We selected a three-arm design to assess the feasibility and preliminary signals of effect for two intervention approaches: MI-PrEP and CETA + MI-PrEP. Although both aim to support PrEP uptake, they target different mechanisms: MI focuses on motivation for behaviour change, while CETA addresses mental health symptoms that may hinder PrEP engagement. Evaluating each separately against TAU (ie, the standard outreach approach) will allow us to determine which approach is more feasible, acceptable and promising to advance to a fully powered trial. A two-arm design would not provide the information needed to refine and select the most appropriate intervention for future testing. The randomisation schedule was prepared by the study statistician (BAN) before trial enrolment began and uploaded into the REDCap database system by the data manager. Participants are randomised to the MI-PrEP, CETA + MI-PrEP or TAU on a 1:1:2 ratio using permuted blocks of varying sizes to ensure balance throughout the study implementation. Randomisation is stratified by whether participants are enrolled in MAT or not. The rest of the study team are masked to the allocation sequence in advance. After entering participant responses to the baseline survey at enrolment into REDCap, the participant is automatically assigned to one of the three study arms within REDCap. The study team member administering the baseline survey then informs the participant of their study arm assignment. Intervention arms Interventions are delivered over up to a 4-month period, with the length of time and schedule for intervention sessions varying based on the assigned intervention arm and treatment plan. All interventions are delivered in person by trained counsellors either at the study site, located within the Muhimbili National Hospital campus in Dar es Salaam, or a location agreed on by the participant and her counsellor. Counsellors include individuals with prior background in peer outreach or social work. One counsellor, who also serves as a supervisor on the study, is a general practitioner in the Department of Psychiatry at the Muhimbili National Hospital in Dar es Salaam. The study leverages the existing national PrEP service delivery infrastructure to facilitate participants’ linkages to PrEP services. Descriptions of each study arm are below: MI PrEP : Participants (n=50) randomised to receive MI-PrEP only receive two 1-hour sessions with an intervention counsellor. The first session includes information on PrEP and other HIV prevention and harm reduction strategies and discussion on PrEP contemplation, importance and confidence and problem-solving around identified barriers to PrEP. The session also includes information on other available harm reduction strategies and services, including medications for opioid use disorder. The second session focuses on following up on any PrEP actions taken, challenges encountered and problem-solving to address challenges. Those ready to be linked to PrEP and/or harm reduction services are offered an escort to a designated PrEP and/or opioid treatment clinic site or other harm reduction services. CETA + MI PrEP : Participants (n=50) randomised to receive CETA + MI-PrEP receive seven to 14 weekly 1-hour sessions from an intervention counsellor. Similar to the MI-PrEP group, women in this study arm receive the two 1-hour MI-PrEP sessions with an intervention counsellor along with a series of 1-hour CETA sessions. For this study, the CETA approach has elements of MI for HIV prevention, including PrEP and other harm reduction embedded throughout the intervention. CETA is a transdiagnostic approach—meaning that it is made of CBT and MI elements that can be combined in various ways, including different sequences, to address clients’ presenting symptoms and problem areas. The intervention counsellor, with the support and oversight by the clinical team, (CETA supervisor and CETA trainer) determines the treatment plan for each participant, that is, the specific intervention component sessions, sequence of sessions and dose or frequency of sessions, based on the primary problem areas identified by the participant and intervention counsellor based on responses to the baseline assessment survey and intake discussions. Participants are provided information on PrEP and offered escorted linkages to a designated PrEP and/or opioid treatment clinic site or other harm reduction services. Enhanced TAU : Participants (n=100) randomised to receive the TAU control arm are provided information on PrEP, substance use disorder treatment and mental health services available and linked to services, if they express an interest. After their final study assessment, participants in the MI-PrEP and TAU study groups will be offered the opportunity to enrol in CETA with a trained CETA counsellor. Participant safety protocol Extensive participant safety procedures are embedded throughout the trial to ensure the prompt identification and management of risks related to suicide, interpersonal violence and opioid overdose. Study personnel, including intervention counsellors and research assistants, received comprehensive training on standardised risk assessments, crisis response and escalation procedures. At enrolment and during follow-up, staff assess for safety risks using structured questions derived from the study’s safety protocol, which was developed in compliance with national mental health and gender-based violence guidelines. If a participant reports suicidal ideation, severe psychological distress or imminent danger from violence, the counsellor immediately notifies the intervention coordinator (FC), a medical doctor and general practitioner in the Psychiatry Department at Muhimbili National Hospital. The participant remains on site to collaboratively develop a safety plan with their counsellor and the intervention coordinator. High-risk participants are escorted to the Psychiatry Department at Muhimbili National Hospital for further evaluation and care, with daily follow-up until the risk has resolved. Safety plans incorporate identification of warning signs, coping strategies and trusted support persons, as well as linkages to medical, psychosocial and legal services, as needed. All safety incidents are documented in a participant safety log, reviewed by supervisors and monitored by the study psychiatrist and co-principal investigator (SL). Confidentiality is maintained in all cases except when disclosure is necessary to protect participant safety, in compliance with Tanzanian laws and guidelines. A data safety and monitoring plan has been developed for the trial, which includes weekly reports of safety concerns and adverse events. The principal investigators (PIs) ensure all protocol modifications and deviations and adverse events are reported to the institutional review boards (IRBs) monitoring the study, according to the applicable regulatory requirements. If any excess harm is observed, the study will be suspended until the PIs are able to consult with monitoring IRBs and the sponsor to make the final determination for stopping the study. If the study is stopped early for any reason, participants will be informed. Baseline and follow-up data collection Baseline and follow-up assessment surveys : Pilot trial participants complete a baseline assessment survey at enrolment and a follow-up survey 6 months post enrolment. Baseline and follow-up surveys assess the preliminary efficacy of the interventions. Surveys take 30–45 min to complete. Assessment surveys include questions on sociodemographic factors (age, relationship status, occupation, number of children, housing status, income), HIV risk behaviours and perceived HIV susceptibility, resilience, PrEP knowledge, PrEP motivations, PrEP contemplation, self-efficacy to perform PrEP behavioural skills and facilitators and barriers to PrEP engagement. Surveys include measures for our preliminary efficacy outcomes, outlined in table 2 . Primary preliminary efficacy outcomes include self-reported PrEP use. PrEP adherence and PrEP persistence were measured using study-specific questions. Secondary preliminary efficacy outcomes include depression measured using the PHQ-9, 54 generalised anxiety measured using the GAD-7, 55 PTSD measured using the HTQ, 56 substance use measured using the Alcohol, Smoking and Substance Involvement Screening Test 59 and violence measured using the WHO’s Violence Against Women Instrument. 60 Follow-up assessment surveys additionally include questions on intervention acceptability, implementation and perceived impacts. Table 2. Key primary and secondary preliminary efficacy outcome measures. Outcome Measure description Primary preliminary outcome PrEP use ‘Have you ever used PrEP for HIV prevention?’ PrEP adherence ‘In the last week, on how many days did you take a dose of PrEP?’ PrEP persistence ‘Are you still using PrEP today?’ Secondary preliminary outcomes Depression Patient Health Questionnaire-9 Generalised anxiety Generalized Anxiety Disorder-7 Post-traumatic stress disorder Harvard Trauma Questionnaire Substance use Alcohol, Smoking and Substance Involvement Screening Test Violence WHO Violence Against Women Instrument Open in a new tab PrEP, pre-exposure prophylaxis for HIV. Client symptom monitoring : At baseline and at the start of each CETA session, CETA + MI-PrEP participants undergo a brief symptom monitoring assessment administered by their counsellors. The client monitoring form tracks changes in symptoms of depression, anxiety, trauma, violence, substance use and/or safety risk throughout the intervention. The data from this form assist in treatment planning and contribute to our assessment of preliminary intervention efficacy as well as providing important information on the number, or dose, of CETA components required to see changes in primary preliminary efficacy outcomes. Counsellor supervision : Following an apprenticeship model of supervision, intervention counsellors meet weekly with trained local supervisors to discuss cases and logistical issues throughout the trial period. Local supervisors keep notes evaluating intervention fidelity and intervention counsellor decision-making for each case. They also provide feedback to counsellors, including feedback on specific cases, on an individual basis. Local supervisors meet at a minimum weekly with the CETA expert supervisor and CETA master trainer to provide supervision and clinical support during the trial. In-depth interviews with trial participants : We are conducting 30 in-depth interviews with a sample of trial participants within a month after completing the intervention who are purposively sampled based on the study arm. 15 participants from the CETA + MI-PrEP study arm and 15 participants from the MI-PrEP only study arm are being interviewed. Interviews are administered by a study team member using a semi-structured interview guide with questions on experiences with the CETA + MI-PrEP or MI-PrEP interventions, experience with their assigned counsellors, PrEP motivation and barriers, PrEP experiences, stress mitigation strategies, safety strategies, engagement in activities and substance use. Interviews are approximately 1 hour and audio-recorded with participant permission and transcribed. In-depth interviews with intervention counsellors : We are also conducting in-depth interviews with all intervention counsellors. Interviews are administered by study team members using a semistructured interview guide with questions on intervention fidelity, barriers and facilitators to delivering the intervention per the intervention protocols and recommendations for future improvements. Interviews with counsellors are 1 hour and audio-recorded with permission and transcribed. Data management All study participants are assigned an unidentifiable, unique study ID code and all study forms are coded with these study ID numbers to maintain participant confidentiality. Hard copies of study documents are stored in locked file cabinets at the study site. Study staff electronically enter all participant contact information, screening, baseline and follow-up assessment survey data using REDCap electronic data capture tools hosted by Muhimbili University of Health and Allied Sciences. 57 58 All deidentified, electronic data, including survey databases, interview and focus group transcripts and other forms will be stored as encrypted files and backed up on a secure, password-protected cloud server, managed by the Information Systems Office at the Johns Hopkins University. Contact information of study participants will be stored separately from study documents and the file linking participant contact information to study data by study ID will be encrypted and password-protected with access restricted to only designated members of the study team. Sample size Prior programme data suggest that approximately 5–10% women in this population initiate PrEP through existing outreach efforts. This pilot trial will confirm the PrEP initiation rate and generate a 95% CI to assess the precision of the estimate, supporting planning for adequately powered future studies. Our resources will allow us to enrol a total of 200 women: 50 women in both the MI-PrEP and CETA + MI-PrEP arms and 100 in the TAU control arm. While efficacy is not the objective of this pilot, this sample size would yield more than 95% statistical power to detect moderate differences (>20%) between the TAU and any of the intervention arms. Data analysis Feasibility outcomes : Data used to assess feasibility include qualitative interview data, follow-up assessment survey data and recruitment and retention data. We are analysing qualitative feasibility data using the framework method. 61 Transcripts and notes are coded using Bowen’s feasibility constructs. 62 We use basic descriptive statistics (eg, frequency distributions, means and medians) to analyse intervention attendance and assessment survey data along the relevant feasibility constructs. Both qualitative and quantitative data are charted using a framework matrix in Excel based on feasibility constructs. We are using a thematic analysis approach to identify common themes by feasibility construct and jointly interpret qualitative and quantitative findings. Table 3 outlines the main feasibility outcomes and relevant benchmarks, where applicable. Table 3. Main feasibility and fidelity outcomes and associated benchmarks for the pilot trial. Outcome Description Data sources Measurable benchmarks Intervention feasibility outcomes Acceptability Perceived appropriateness and satisfaction with the intervention Follow-up assessment survey; indepth interviews ≥70% satisfied or very satisfied with the intervention Demand Extent to which there is demand for the intervention Trial attendance and retention databases; indepth interviews ≥70% completing all planned sessions Mean proportion of planned sessions attended Recruitment feasibility Extent to which recruitment and enrolment targets are met Recruitment and enrolment reports ≥70% of eligible participants enrolled ≥70% of enrolment target achieved Retention feasibility Extent to which participants are retained in the study for follow-up assessments Follow-up assessment surveys ≥50% completing 6-month follow-up survey assessment Intervention fidelity outcomes Delivery Extent to which the intervention is delivered as intended Training observations; counsellor supervision; indepth interviews Descriptive Receipt Extent to which participants demonstrate that they understand and can perform the skills presented in the intervention Indepth interviews Descriptive Enactment Extent to which participants perform intervention-related skills and strategies in real-life settings Indepth interviews Descriptive Open in a new tab Fidelity outcomes : We draw from counsellor training observations and assessments, counsellor supervision assessments, follow-up assessment surveys and indepth interviews with trial participants and counsellors to assess intervention fidelity along the dimensions: delivery, receipt and enactment ( table 3 ). Training observations, training and counsellor supervision assessments, follow-up assessment surveys and indepth interviews are analysed using the framework method with Bellg’s Treatment Fidelity Framework 63 guiding coding and the framework matrix. Preliminary efficacy outcomes : We will present summary statistics of categorical or continuous variables as appropriate to describe socio-demographic characteristics of all trial participants in each study arm. We will also calculate proportions for the primary preliminary efficacy outcomes (PrEP action, initiation and adherence) and corresponding 95% CIs using large sample approximations or exact Binomial distribution if the counts of success are small. An absolute difference in the outcomes proportions will be calculated alongside the corresponding 95% CI. Exploratory analyses will include investigating individual sociodemographic characteristics associated with PrEP engagement using logistic or log-binomial regression models. Similar exploratory analyses will be performed for mental health outcomes and drug use using appropriate linear or generalised regression models. We will handle missing data using multiple imputation approaches. Ethics and dissemination All study participants provide written informed consent prior to enrolment in the study. Study procedures were approved by the Johns Hopkins Bloomberg School of Public Health IRB (protocol number: 25580), the Muhimbili University of Health and Allied Sciences Ethics Review Committee (protocol number: MUHAS-REC-12-2023-1994) and the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (protocol number: NIMR/HQ/R.8a/Vol.IX/4830). Trial results will be reported to ClinicalTrials.gov and peer-reviewed journals in accordance with Consolidated Standards of Reporting Trials guidelines for pilot and feasibility trials. Results will also be presented at scientific conferences and to local partners in Tanzania, including partner recruitment sites, and other social service and health organisations offering services for women who use drugs, through community meetings and research briefs. Individual deidentified participant-level data will be available through the National Addiction & HIV Data Archive Program digital data repository of the Inter-university Consortium for Political and Social Research 1 year after the last study assessment. Status of trial Recruitment for the pilot trial began in July 2025. As of 4 December 2025, 123 participants have been enrolled. We expect to complete the trial and all assessments by June 2026. No interim analyses are planned. The trial was initially registered with ClinicalTrials.gov on 14 February 2025 under the ID NCT06835751 . Discussion This pilot randomised controlled trial presents an important opportunity to address the complex interplay of mental health and HIV prevention among women who use drugs. By focusing on evidence-based interventions that consider the unique needs of this population, we will develop and evaluate strategies that can enhance both mental health and HIV prevention. This pilot trial has several strengths. First, it addresses comorbid conditions commonly experienced by women who use drugs. The individualised transdiagnostic intervention (CETA) is built to target multiple behavioural and mental health problems, which are highly prevalent in women who use drugs in this setting. Second, the refinement of MI-PrEP and the combined CETA + MI-PrEP have the potential to be interventions that can be delivered at the community level by paraprofessionals, including peer outreach workers or lay counsellors with no or limited previous mental health training. Third, given the flexibility of CETA to treat individuals presenting with different mental disorder symptoms, this trial will provide critical information about how CETA + MI-PrEP can be adopted to improve PrEP engagement among other populations with similar high co-occurrence of substance use and mental health problems. Supplementary material online supplemental material 1 bmjopen-16-1-s001.pdf (210.7KB, pdf) DOI: 10.1136/bmjopen-2025-114522 Footnotes Funding: This work was supported by the U.S. National Institute on Drug Abuse grant number R34DA058566. The sponsor has no role in the design, conduct, analysis, and reporting of trial results. prepub: Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online ( https://doi.org/10.1136/bmjopen-2025-114522 ). Patient consent for publication: Consent obtained directly from patient(s). 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