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

NCT06835751 | Active Not Recruiting

• 2 other identifiers: IRB00025580R34DA058566
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Mental Health; Substance Use (Drugs, Alcohol)

Keywords

HIV pre-exposure prophylaxis (PrEP); Mental health; substance use

Outcome Measures

Primary Outcomes (7)

• Proportion of eligible participants who enroll

  Proportion of eligible participants who enroll (Recruitment feasibility)

  At baseline

• Proportion of target sample size enrolled

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

  At baseline

• Mean proportion of planned sessions attended

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

  6 months post-enrollment

• Proportion completing all planned sessions

  Proportion completing all planned sessions (Intervention delivery feasibility)

  6-months post-enrollment

• Proportion completing follow-up survey assessment

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

  6 months post-enrollment

• Proportion satisfied with the intervention

  Proportion satisfied or very satisfied with the intervention

  6 months post-enrollment

• Proportion of participants who report PrEP initiation

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

  6 months post-enrollment

Secondary Outcomes (5)

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

  Baseline and 6 months post-enrollment

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

  Baseline and 6 months post-enrollment

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

  Baseline and 6 months post-enrollment

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

  Baseline and 6 months post-enrollment

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

  Baseline and 6 months post-enrollment

Study Arms (3)

Motivational Interviewing for PreP (MI-PrEP)

EXPERIMENTAL

Participants randomized to this arm 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.

Behavioral: Motivational Interviewing for PreP

Common Elements Treatment Approach (CETA) + MI-PrEP

EXPERIMENTAL

Participants randomized to this arm 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.

Behavioral: Common Elements Treatment Approach (CETA) + MI-PrEP

Treatment as Usual (TAU)

NO INTERVENTION

Participants randomized to this arm will receive the treatment as usual. Participants will be offered information on PrEP, including its benefits and potential side effects, and PrEP, substance use disorder treatment, including medications for opioid use disorder, overdose prevention and management, and mental health services available, as well as optional escorted linkage to a designated PrEP and/or opioid treatment clinic site. Participants will be offered linkages to a designated PrEP and/or opioid treatment clinic site or other harm reduction services, in line with current community outreach practices.

Interventions

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.

Motivational Interviewing for PreP (MI-PrEP)

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.

Common Elements Treatment Approach (CETA) + MI-PrEP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Muhimbili University of Health and Allied Sciences: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Related Publications (1)

• Saleem H, Atkins K, Skavenski S, Nonyane BA, Chitamwebwa F, Mtaita S, Mwansa D, Luswetula A, Murray LK, Likindikoki S. 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. BMJ Open. 2026 Jan 8;16(1):e114522. doi: 10.1136/bmjopen-2025-114522.

  PMID: 41506761 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Haneefa T Saleem, PhD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Individual participant-level data (IPD) will be available 12 months after the end of data collection
• Access Criteria: Public Use Data: All deidentified study data that are not designated as restricted use will be made available as public use data to the research community via Data Sharing for Demographic Research (DSDR). Users of the public use data must register with ICPSR and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads. Restricted Access Data: Data that are determined to be potentially identifying through indirect or deductive disclosure are provided under restricted data contract to users who demonstrate a valid research need and meet conditions of use. Access to restricted study data is available via a virtual data enclave system at NAHDAP/ICPSR.

Locations

TA (1)