Comparing individual and group interventions to reduce HIV and STIs in African-born women
Comparative Effectiveness of Individual Versus Group-level Interventions to Reduce HIV Risk Among African Immigrant Women
This study is testing two new culturally adapted programs to see if they can help African-born women in the US use condoms more often and start taking HIV prevention medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT06022809 on ClinicalTrials.gov |
What this trial studies
This study aims to address the high rates of HIV among African-born Black women in the US by culturally adapting two effective HIV prevention interventions originally designed for US-born Black women. The interventions, Sister-to-Sister (S2S) and Sisters Informing Sisters about Topics on AIDS (SISTA), will be modified and renamed to resonate with African culture, becoming Dada Kwa Dada (DKD) for individual-level intervention and DADA for group-level intervention. A randomized controlled trial will then compare the effectiveness of these adapted interventions in increasing condom use and pre-exposure prophylaxis (PrEP) uptake among the target population. The study will take place in Greater Boston and New York City, focusing on women aged 18 to 45 who are HIV-negative and have reported condomless sex.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-negative cis-gender women aged 18 to 45, born in an African country, currently living in Greater Boston or New York City, and fluent in English or French.
Not a fit: Patients who are cis-gender men, transgender individuals, or pregnant women will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce HIV and STI incidence among African-born women in the US.
How similar studies have performed: Other studies have shown success with culturally adapted interventions for HIV prevention, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HIV-negative * Born in an African country * Currently living in Greater Boston Area or New York City * Cis-gender woman * Self-reported Black or mixed-Black race * Fluent in English or French * Ages between 18 and 45 * Report of condomless vaginal or anal sex with one or more male(s) in the last 3 months prior to enrollment Exclusion Criteria: - Cis-gender man, transgender woman, transgender man, Pregnant woman
Where this trial is running
Boston, Massachusetts and 2 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Whittier Street Health Center — Roxbury, Massachusetts, United States (Active_not_recruiting)
- Muslim Women's Insitute for Research and Development — Bronx, New York, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Bisola O. Ojikutu, MD, MPH — Brigham and Women's Hospital
- Study coordinator: Principal Investigator
- Email: bojikutu@bwh.harvard.edu
- Phone: 917-287-2710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.