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NCT Number: NCT06835751

Optimizing HIV Pre-exposure Prophylaxis (PrEP) Among Women Who Use Drugs in Tanzania

This study is testing two different approaches to help women who use drugs in Tanzania take and continue using HIV prevention medication called pre-exposure prophylaxis (PrEP). Women who use drugs face a higher risk of HIV infection, but many do not start or continue PrEP due to barriers like stigma, mental health challenges, and lack of support.

The study will enroll 200 women who use drugs in Dar es Salaam, Tanzania. These women will be randomly assigned to one of three groups:

Motivational Interviewing for PrEP (MI-PrEP) Only - Women in this group will receive two one-hour counseling sessions focused on HIV prevention, PrEP education, and problem-solving to help the women start and continue using PrEP.

Common Elements Treatment Approach (CETA) + MI-PrEP - Women in this group will receive the same MI-PrEP counseling sessions plus additional mental health counseling (up to 14 sessions) tailored to the women's individual needs, addressing issues like depression, anxiety, trauma, and substance use.

Treatment as Usual (TAU) - Women in this group will receive basic information on PrEP, mental health, and harm reduction, along with optional referrals to PrEP or drug treatment clinics.

The study will evaluate feasibility of administering MI-PrEP and CETA+MI-PrEP and how well these interventions help women start and stay on PrEP, as well as the intervention's impact on mental health and drug use. Researchers will also interview participants and counselors to understand the participants and counselors experiences with the program.

The goal is to find effective ways to support PrEP use among women who use drugs and to develop a model that could be used in similar settings to reduce HIV risk. This pilot study is approved by ethics committees in the United States and Tanzania, and results will be shared with communities, policymakers, and researchers.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Behavior Chemically-Induced Disorders Mental Disorders Mental Health Personal Satisfaction Psychological Well-Being Substance Use (Drugs, Alcohol) Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

About this study

This study is a pilot clinical trial aiming to assess the feasibility and preliminary efficacy of two interventions designed to improve PrEP engagement among women who use drugs (WWUD) in Dar es Salaam, Tanzania. The trial will enroll 200 participants who will be randomly assigned to one of three study arms: Motivational Interviewing for PrEP (MI-PrEP) only, Common Elements Treatment Approach (CETA) + MI-PrEP, or Enhanced Treatment as Usual (TAU). The study will evaluate whether these interventions can enhance PrEP uptake and adherence, while also addressing mental health and substance use challenges common among WWUD.

WWUD in Tanzania are at a heightened risk of acquiring HIV due to intersecting vulnerabilities, including drug use, high-risk sexual behaviors, and gender-based disparities. Although PrEP is a proven HIV prevention method, uptake among this population remains low due to stigma, limited healthcare access, and co-occurring mental health conditions. To address these barriers, this pilot trial will implement and evaluate MI-PrEP, a brief intervention designed to enhance motivation for PrEP use, and CETA + MI-PrEP, a more intensive mental health intervention that combines MI-PrEP with a modular, trans-diagnostic therapy addressing depression, anxiety, trauma, and substance use.

The MI-PrEP intervention will consist of two one-hour counseling sessions providing PrEP education, motivation enhancement, and problem-solving strategies. Participants in the CETA + MI-PrEP arm will receive the same MI-PrEP sessions in addition to up to 14 weekly CETA sessions tailored to individual mental health and substance use needs. The TAU control group will receive PrEP education, mental health and substance use resources, and optional referrals to PrEP and harm reduction services. The primary outcomes of the study will be feasibility, PrEP uptake, and adherence at one and six months post-intervention. Secondary outcomes include changes in depression, anxiety, PTSD symptoms, substance use behaviors, and HIV risk behaviors.

Participants will complete baseline, one-month, and six-month follow-up assessments. Quantitative data will be collected through structured surveys, while qualitative data will be obtained from in-depth interviews with a subset of trial participants and intervention counselors. Thematic analysis will be used to assess intervention feasibility, fidelity, and perceived impact. Statistical analyses, including logistic regression and mixed-effects models, will evaluate intervention effects on PrEP uptake, adherence, and mental health outcomes.

Safety protocols will be implemented to assess and manage risks related to suicide, homicide, interpersonal violence, and overdose. Ethical approvals have been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board, the Muhimbili University of Health and Allied Sciences Ethics Review Committee, and the National Institute for Medical Research in Tanzania. The study also involves a Community Advisory Board (CAB) composed of WWUD and a Study Advisory Board (SAB) including representatives from academia, civil society, government agencies as well as healthcare providers and WWUD to ensure ethical and community-informed implementation.

Findings from this pilot trial will inform scalable strategies to support PrEP uptake among WWUD and other key populations at high risk for HIV infection. The results will be disseminated through community meetings, scientific conferences, and peer-reviewed publications, contributing to improved HIV prevention programming for WWUD in Tanzania and beyond.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female sex
  • 18 years or older
  • Non-reactive or negative HIV test result
  • Self-reported drug- or sex-related HIV risk behaviors in the past six months
  • Hazardous or harmful opioid use in the past six months
  • Meets criteria for at least one of the following co-occurring mental health conditions: symptoms of depression (PHQ-9 >= 9), anxiety (GAD-7 >= 10), and/or PTSD (HTQ >= 40)

Exclusion criteria

  • Reactive or positive HIV test result
  • Currently taking PrEP
  • Actively suicidal, homicidal, or psychotic, and needing immediate hospitalization based on safety assessments
  • Unable to provide informed consent

Treatment and study plan

Motivational Interviewing for PreP

Behavioral

Participants will receive MI-PrEP only will receive two 1-hour sessions with an intervention counselor. The first session will include 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 will also include information on other available harm reduction strategies and services, including medications for opioid use disorder. The second session will focus on following up on any PrEP actions taken, challenges encountered, and problem-solving to address any challenges. Those ready to be linked to PrEP and/or harm reduction services will be offered an escort to a designated PrEP and/or opioid treatment clinic site or other harm reduction services.

Common Elements Treatment Approach (CETA) + MI-PrEP

Behavioral

Participants will receive CETA+MI-PrEP will receive 7 to 14 weekly one-hour sessions from an intervention counselor. Similar to the MI-PrEP group, women in this study arm will receive the two 1-hour MI-PrEP sessions with an intervention counselor with linkages to PrEP and/or harm reduction services. Women will then begin CETA sessions. The CETA intervention component is a modular and flexible approach comprised of nine elements that can be combined in various ways, including different sequences, to address clients' presenting symptoms and problem areas. CETA currently includes key engagement strategies, including MI, throughout the intervention. The intervention counselor will determine the specific intervention component sessions, sequence of sessions, and dose, or frequency of sessions, based on the primary problem area identified by the participant and intervention counselor as reported in the baseline assessment survey and initial discussions.

Primary outcomes

  1. Proportion of eligible participants who enroll

    Time frame: At baseline

    Proportion of eligible participants who enroll (Recruitment feasibility)

  2. Proportion of target sample size enrolled

    Time frame: At baseline

    Proportion of target sample size enrolled in the study - Actual number of women enrolled/Planned number of women to enroll (Recruitment feasibility)

  3. Mean proportion of planned sessions attended

    Time frame: 6 months post-enrollment

    Mean attendance rate, i.e., proportion of planned sessions attended (Demand & engagement)

  4. Proportion completing all planned sessions

    Time frame: 6-months post-enrollment

    Proportion completing all planned sessions (Intervention delivery feasibility)

  5. Proportion completing follow-up survey assessment

    Time frame: 6 months post-enrollment

    Proportion completing 6-month follow-up survey assessment (Retention feasibility)

  6. Proportion satisfied with the intervention

    Time frame: 6 months post-enrollment

    Proportion satisfied or very satisfied with the intervention

  7. Proportion of participants who report PrEP initiation

    Time frame: 6 months post-enrollment

    Self-reported survey measures: 1) Have you been prescribed PrEP medications? and 2) Have you received PrEP medications within 3 months of HIV testing?

Secondary outcomes

  1. Change from baseline in depressive symptoms at 6 months as assessed by the PHQ-9

    Time frame: Baseline and 6 months post-enrollment

    Change from baseline in depressive symptoms at 6 months post-enrolled as assessed by the Patient Health Questionnaire-9 (PHQ-9); Scoring: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (range of 0-27)

  2. Change from baseline in general anxiety symptoms at 6 months as assessed by GAD-7

    Time frame: Baseline and 6 months post-enrollment

    Change from baseline in general anxiety symptoms at 6 months post-enrollment as assessed by the Generalized Anxiety Disorder-7 (GAD-7); 7-item scale (GAD-7) range from 0 to 21, higher scores reflect greater symptom severity.

  3. Change from baseline in PTSD symptoms at 6 months as assessed by HTQ

    Time frame: Baseline and 6 months post-enrollment

    Change from baseline in post-traumatic stress disorder (PTSD) symptoms at 6 months as assessed by the Harvard Trauma Questionnaire (HTQ); Score range 16-64. Higher scores indicate higher levels of PTSD symptoms

  4. Change from baseline in substance use risk score at 6 months as assessed by ASSIST Global Continuum of Illicit Drug Risk Score

    Time frame: Baseline and 6 months post-enrollment

    Change from baseline in substance use risk score at 6 months as assessed by the Alcohol, Smoking, and Substance Involvement Screening (ASSIST) Global Continuum of Illicit Drug Risk Score. Score ranges from 0 to 308, with higher scores indicating greater risk

  5. Change from baseline in gender-based violence score at 6 months as assessed by VAWI

    Time frame: Baseline and 6 months post-enrollment

    Change from baseline in gender-based violence score at 6 months as assessed by the World Health Organization (WHO) Violence Against Women Instrument (VAWI). 13 Yes/No questions. Higher score reflect higher gender based violence.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Optimizing PrEP Among Women Who Use Drugs in Tanzania

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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