RECRUITING

Comparative Effectiveness of Individual Versus Group-Level Interventions to Reduce Human Immunodeficiency Virus (HIV)/ Sexually Transmitted Infections (STI) Incidence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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. The adapted versions of these interventions will be given new names that resonate with the African culture. The adapted version of S2S intervention will be called "Dada Kwa Dada (DKD)" intervention while the adapted version of SISTA intervention will be called "DADA" intervention. "DADA" means "Sister" in Swahili and other languages in Eastern and Western Africa.

Official Title

Comparative Effectiveness of Individual Versus Group-level Interventions to Reduce HIV Risk Among African Immigrant Women

Quick Facts

Study Start:2023-11-02
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06022809

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * HIV-negative
  2. * Born in an African country
  3. * Currently living in Greater Boston Area or New York City
  4. * Cis-gender woman
  5. * Self-reported Black or mixed-Black race
  6. * Fluent in English or French
  7. * Ages between 18 and 45
  8. * Report of condomless vaginal or anal sex with one or more male(s) in the last 3 months prior to enrollment
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Principal Investigator
CONTACT
917-287-2710
bojikutu@bwh.harvard.edu
Study Director
CONTACT
415-810-0675
gmaganga@bwh.harvard.edu

Principal Investigator

Bisola O. Ojikutu, MD, MPH
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Gray M. Maganga, MS
STUDY_DIRECTOR
Brigham and Women's Hospital
Laura Bogart, PhD
STUDY_CHAIR
RAND Corporation Inc
Khady Diouf, MD
STUDY_CHAIR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Whittier Street Health Center
Roxbury, Massachusetts, 02120
United States
Muslim Women's Insitute for Research and Development
Bronx, New York, 10452
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Bisola O. Ojikutu, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital
  • Gray M. Maganga, MS, STUDY_DIRECTOR, Brigham and Women's Hospital
  • Laura Bogart, PhD, STUDY_CHAIR, RAND Corporation Inc
  • Khady Diouf, MD, STUDY_CHAIR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • HIV
  • Other STIs