Optimizing PrEP Among Women Who Use Drugs in Tanzania

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
United Republic of Tanzania
Muhimbili University of Health and Allied Sciences
RECRUITING
Dar Es Salaam
Contact Information
Primary
Haneefa T Saleem, PhD, MPH
haneefa.saleem@jhu.edu
443-287-5130
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 200
Treatments
Experimental: Motivational Interviewing for PreP (MI-PrEP)
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.
Experimental: Common Elements Treatment Approach (CETA) + MI-PrEP
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.
No_intervention: Treatment as Usual (TAU)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Muhimbili University of Health and Allied Sciences, National Institute on Drug Abuse (NIDA)
Leads: Johns Hopkins Bloomberg School of Public Health

This content was sourced from clinicaltrials.gov