424 Participants Needed

Group vs Individual Interventions for HIV Prevention

Recruiting at 2 trial locations
PI
SD
Overseen ByStudy Director
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment DADA, Sisters Informing Sisters about Topics on AIDS (SISTA), DADA, Dada Kwa Dada, DKD, Dada Kwa Dada, Adapted Sister-to-Sister Intervention for HIV prevention?

Research shows that the SISTA intervention, which is part of the treatment, led to a significant reduction in sexual risk behaviors among African American women, such as having less unprotected sex, when implemented in community settings.12345

Is the SISTA intervention for HIV prevention safe for humans?

The available research on the SISTA intervention, which is designed for HIV prevention among African American women, does not report any safety concerns or adverse effects, suggesting it is generally safe for human participants.13567

How is the DADA treatment unique for HIV prevention?

The DADA treatment, also known as SISTA, is unique because it is a culturally relevant, gender-specific group intervention designed specifically for African American women, focusing on reducing sexual risk through education and empowerment in a supportive group setting.238910

What is the purpose of this trial?

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 women2. 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.

Research Team

BO

Bisola O. Ojikutu, MD, MPH

Principal Investigator

Brigham and Women's Hospital

GM

Gray M. Maganga, MS

Principal Investigator

Brigham and Women's Hospital

LB

Laura Bogart, PhD

Principal Investigator

RAND Corporation Inc

KD

Khady Diouf, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for HIV-negative, African-born Black or mixed-Black cis-gender women aged 18-45 living in Greater Boston Area or New York City. Participants must speak English or French and have had unprotected sex recently. Pregnant women, men, and transgender individuals cannot join.

Inclusion Criteria

HIV-negative
You were born in an African nation.
You are domiciled in either the Greater Boston region or New York City.
See 3 more

Exclusion Criteria

I am a cisgender man.
I am a transgender man.
Pregnant woman
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline Assessment and Randomization

Participants complete baseline assessments and are randomized to either the individual-level or group-level intervention

1 week
1 visit (in-person)

Intervention Delivery

Participants receive either the Dada Kwa Dada (individual-level) or DADA (group-level) intervention virtually

2 weeks
Virtual sessions

Follow-up

Participants are monitored for primary outcomes such as PrEP uptake and condom use at 3 and 6 months

6 months
Follow-up assessments at 3 and 6 months

Treatment Details

Interventions

  • DADA
  • Dada Kwa Dada
Trial Overview The study tests two adapted HIV prevention interventions: 'Dada Kwa Dada' (DKD) for individual-level education and 'DADA' for group sessions. Both aim to increase condom use and PrEP uptake among participants to reduce HIV/STI incidence.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group-level interventionExperimental Treatment1 Intervention
Virtual group sessions
Group II: Individual-level interventionActive Control1 Intervention
Virtual one-on-one session

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Boston University

Collaborator

Trials
494
Recruited
9,998,000+

RAND

Collaborator

Trials
145
Recruited
617,000+

The Fenway Institute

Collaborator

Trials
15
Recruited
2,900+

Whittier Street Health Center

Collaborator

Trials
1
Recruited
420+

Muslim Women's Institute for Research and Development

Collaborator

Trials
1
Recruited
420+

Harvard Street Neighborhood Health Center

Collaborator

Trials
1
Recruited
420+

Harvard Medical School (HMS and HSDM)

Collaborator

Trials
208
Recruited
1,421,000+

Findings from Research

The SISTA intervention, aimed at reducing HIV rates among African American women, highlights the critical need for targeted prevention strategies in this demographic.
The pilot project revealed that community-based organizations require significant pre-planning and skills-building to effectively implement HIV prevention programs, indicating a gap in training and resources for service providers.
The SISTA pilot project: understanding the training and technical assistance needs of community-based organizations implementing HIV prevention interventions for African American women--implications for a capacity building strategy.Fuller, TR., Brown, M., King, W., et al.[2022]
A systematic review of 11 analyses on behavioral change interventions for preventing HIV transmission among women and girls in low- and middle-income countries found that only two interventions significantly reduced HIV incidence.
Out of ten analyses measuring behavioral outcomes, only three showed a reduction in HIV-related risk behaviors, indicating that more research is needed to assess the effectiveness of these interventions as standalone or complementary strategies in HIV prevention.
Behavior change interventions to prevent HIV infection among women living in low and middle income countries: a systematic review.McCoy, SI., Kangwende, RA., Padian, NS.[2018]
The SISTA intervention, designed specifically for African American women, effectively reduced sexual risk behaviors among participants, with significant improvements observed at both 90 and 180 days post-intervention.
In a study involving 432 women, participants showed a marked decrease in risky sexual behaviors, including unprotected sex, highlighting the intervention's efficacy in promoting safer sexual practices.
Evaluation of an HIV prevention intervention designed for African American Women: results from the SISTA Community-Based Organization Behavioral Outcomes Project.Sapiano, TN., Moore, A., Kalayil, EJ., et al.[2022]

References

The SISTA pilot project: understanding the training and technical assistance needs of community-based organizations implementing HIV prevention interventions for African American women--implications for a capacity building strategy. [2022]
Behavior change interventions to prevent HIV infection among women living in low and middle income countries: a systematic review. [2018]
Evaluation of an HIV prevention intervention designed for African American Women: results from the SISTA Community-Based Organization Behavioral Outcomes Project. [2022]
Mediation analysis of an effective sexual risk-reduction intervention for women: the importance of self-efficacy. [2022]
Effectiveness of an evidence-based HIV prevention intervention when implemented by frontline providers. [2023]
Efficacy of a health educator-delivered HIV prevention intervention for Latina women: a randomized controlled trial. [2021]
Lessons learned from field-testing a brief behavioral intervention package for African American women at risk for HIV/STDs. [2022]
Prevention of sexual risk behavior for HIV infection with women. [2007]
Impact of peer group education on HIV prevention among women in Botswana. [2006]
A meta-analysis of the efficacy of HIV/AIDS prevention interventions in Asia, 1995-2009. [2021]
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