Comparative Effectiveness of Individual Versus Group-Level Interventions to Increase PrEP Uptake and Reduce HIV/STI Incidence
NCT06022809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149
Last updated 2026-02-27
Summary
The HIV diagnosis rate among African-born Black women is the highest of all Black individuals living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis (PrEP) are two effective means of decreasing HIV risk among women, but they remain suboptimal among Black women.
The specific aims of this study are:
1. To culturally adapt two widely utilized, evidence-based HIV prevention interventions originally designed for US born Black women (Sister-to-Sister (S2S) and Sisters Informing Sisters about Topics on AIDS (SISTA)) for use by African-born women.
To ensure the interventions resonated with African culture, they were given new names. The adapted S2S program was renamed as 'Dada Kwa Dada' (DKD), and the SISTA adaptation as 'DADA.' In Swahili and various other languages across East and West Africa, 'dada' means 'sister'.
2. To conduct a randomized controlled comparative effectiveness trial (RCT) to determine the effectiveness of adapted versions of S2S versus SISTA on increasing condom use and PrEP uptake among African-born women.
This study compares the effectiveness of an individual versus a group-level intervention to increase pre-exposure prophylaxis (PrEP) uptake, condom use, and HIV testing and decrease the incidence of HIV and other sexually transmitted infections (STIs).
Conditions
- HIV
- Other STIs
Interventions
- BEHAVIORAL
-
Dada Kwa Dada (individual-level)
Dada Kwa Dada (DKD) intervention is an adapted version of Sister to Sister (S2S) intervention (a brief, health profession-led, individual-level intervention proven to increase condom use and decrease STIs among African American women). Intervention is a 1hr to 1.5hrs session and offered in English or French.
- BEHAVIORAL
-
DADA (group-level)
DADA intervention is an adapted version of Sisters Informing Sisters about Topics on AIDS (SISTA) intervention (a peer-led, group-level intervention proven to increase condom use and decrease STIs among African American women). This is a 6hrs intervention implemented in two three-hour sessions and offered in English or French.
Sponsors & Collaborators
-
RAND
collaborator OTHER -
The Fenway Institute
collaborator OTHER -
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Boston University
collaborator OTHER -
Muslim Women's Institute for Research and Development
collaborator OTHER -
Whittier Street Health Center
collaborator UNKNOWN -
Harvard Street Neighborhood Health Center
collaborator UNKNOWN -
Harvard Medical School (HMS and HSDM)
collaborator OTHER -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Bisola O. Ojikutu, MD, MPH · Brigham and Women's Hospital
-
Gray M. Maganga, MS · Brigham and Women's Hospital
-
Laura Bogart, PhD · RAND Corporation Inc
-
Khady Diouf, MD · Brigham and Women's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-02
- Primary Completion
- 2026-01-26
- Completion
- 2026-01-26
Countries
- United States
Study Locations
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