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

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06022809 on ClinicalTrials.gov