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Search / Trial NCT06835751

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

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · Feb 14, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Hiv Pre Exposure Prophylaxis (Pr Ep) Mental Health Substance Use

ClinConnect Summary

This clinical trial is focused on finding ways to help women in Tanzania who use drugs take and continue using a medication called pre-exposure prophylaxis (PrEP) to prevent HIV. Women who use drugs are at a higher risk for HIV, but many struggle to start or keep using PrEP due to challenges like stigma, mental health issues, and lack of support. The study will involve 200 women who will be placed in one of three groups: one group will receive counseling specifically about PrEP, another group will get both PrEP counseling and additional mental health support, and the last group will receive standard information about PrEP and referrals to other services.

To participate in this trial, women need to be 18 years or older, have a negative HIV test, and report certain risk behaviors related to HIV in the past six months, along with mental health challenges like depression or anxiety. During the study, participants can expect to receive tailored support that addresses both their HIV prevention needs and any mental health concerns. The goal is to develop effective strategies to help women use PrEP and reduce their risk of HIV, and the findings will be shared with communities and healthcare providers to improve support for women in similar situations.

Gender

FEMALE

Eligibility criteria

  • 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

About Johns Hopkins Bloomberg School Of Public Health

The Johns Hopkins Bloomberg School of Public Health is a leading institution dedicated to advancing public health research and education. Renowned for its rigorous academic programs and commitment to improving global health outcomes, the School conducts innovative clinical trials that address pressing health challenges. With a focus on evidence-based practices, multidisciplinary collaboration, and community engagement, the Bloomberg School leverages its extensive resources and expertise to contribute to the development of effective public health interventions and policies. Through its research endeavors, the School aims to enhance population health and inform health policy both locally and globally.

Locations

Patients applied

0 patients applied

Trial Officials

Haneefa T Saleem, PhD, MPH

Principal Investigator

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported