Comparative Effectiveness of Individual Versus Group-Level Interventions to Increase PrEP Uptake and Reduce HIV/STI Incidence

NCT06022809 | Completed

• 2 other identifiers: 2023P001336125110
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 3

Brief 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. 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.
2. 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.

Conditions

HIV; Other STIs

Keywords

HIV; African-born women; Condom use; Pre-exposure Prophylaxis

Outcome Measures

Primary Outcomes (4)

• Proportion of participants who used condom during their last sexual intercourse

  Condom use at last sexual intercourse (Self-report yes/no) change from baseline to each followup)

  3-month and 6-months after intervention

• Proportion of participants who obtained PrEP prescriptions.

  Participants who obtained prescription for PrEP (Self-report/medical record review)

  3-months and 6-months after intervention

• Proportion of participants who are willing to take PrEP in the next 12 months.

  Participants who reported that they were extremely unlikely, very unlikely, somewhat unlikely, not sure, somewhat likely, very likely or extremely likely willing to take PrEP.

  3-months and 6-months after intervention

• Proportion of participants who took PrEP through pill or injection.

  Participants who took daily PrEP pills or PrEP injection.

  3-months and 6-months after intervention

Secondary Outcomes (3)

• Proportion of participants who tested positive for STI.

  6-months after intervention

• Proportion of participants who accepted HIV testing.

  6-months after intervention

• Proportion of participants with intention to get tested for HIV in the next 6 months.

  6-months after intervention

Study Arms (2)

Individual-level intervention

ACTIVE COMPARATOR

Virtual one-on-one session

Behavioral: Dada Kwa Dada (individual-level)

Group-level intervention

EXPERIMENTAL

Virtual group sessions

Behavioral: DADA (group-level)

Interventions

Dada Kwa Dada (individual-level) BEHAVIORAL

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.

Individual-level intervention

DADA (group-level) BEHAVIORAL

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.

Group-level intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Cis-gender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Cis-gender man, transgender woman, transgender man, Pregnant woman

Sponsors & Collaborators

• Boston University: collaborator
• Muslim Women's Institute for Research and Development: collaborator
• Whittier Street Health Center: collaborator
• Harvard Street Neighborhood Health Center: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Massachusetts General Hospital: lead
• RAND: collaborator
• The Fenway Institute: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Whittier Street Health Center

Roxbury, Massachusetts, 02120, United States

Location

Muslim Women's Insitute for Research and Development

The Bronx, New York, 10452, United States

Location

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Study Officials

• Bisola O. Ojikutu, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Gray M. Maganga, MS

  Brigham and Women's Hospital

  STUDY DIRECTOR

• Laura Bogart, PhD

  RAND Corporation Inc

  STUDY CHAIR

• Khady Diouf, MD

  Brigham and Women's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: In this study, we have a two-arm parallel assignment, with each arm receiving a different intervention (individual-level vs. group-level).

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: November 2, 2023
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)