Group vs Individual Interventions for HIV Prevention

Recruiting at 2 trial locations

Overseen By Study Director

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cis-gender man, transgender, pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

424 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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. ^{2 3 8 9 10}

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 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.

Research Team

Bisola O. Ojikutu, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Laura Bogart, PhD

Principal Investigator

RAND Corporation Inc

Gray M. Maganga, MS

Principal Investigator

Brigham and Women's Hospital

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.

Exclusion Criteria

I am a cisgender man.

I am a transgender man.

Pregnant woman

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

Group I: Group-level intervention Experimental Treatment 1 Intervention

Virtual group sessions

Group II: Individual-level intervention Active Control 1 Intervention

Virtual one-on-one session

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Sister-to-Sister intervention significantly reduced sexual risk behaviors and STD incidence among African American women, demonstrating its effectiveness as a skill-building program.

Self-efficacy for condom use was identified as the key factor mediating the intervention's success, indicating that empowering women to feel confident in their ability to use condoms is crucial for improving sexual health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediation analysis of an effective sexual risk-reduction intervention for women: the importance of self-efficacy. O'Leary, A., Jemmott, LS., Jemmott, JB.[2022]

The SISTA intervention, aimed at reducing HIV risk among heterosexual African American women, did not show a significant change in the odds of unprotected sex among participants, despite being an evidence-based program.

In contrast, participants receiving standard HIV counseling, testing, and referral (CTR) experienced a 38% decrease in the odds of having unprotected sex over time, suggesting that the SISTA intervention may not be as effective in real-world implementation as previously established in controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an evidence-based HIV prevention intervention when implemented by frontline providers. Owczarzak, J., Broaddus, M., Tarima, S.[2023]

The AMIGAS intervention significantly improved condom use among 252 Latina women aged 18 to 35, with participants reporting over four times more consistent use compared to those in a standard health intervention.

Participants in the AMIGAS program also showed increased self-efficacy in negotiating safer sex, reduced traditional gender role beliefs, and greater overall knowledge about HIV, indicating a comprehensive approach to enhancing sexual health among Latina women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a health educator-delivered HIV prevention intervention for Latina women: a randomized controlled trial. Wingood, GM., DiClemente, RJ., Villamizar, K., et al.[2021]

The Sister to Sister intervention, designed to address HIV/STD prevention among African American women, was successfully adapted for national dissemination through collaboration with community partners and field-testing in three clinical settings.

Implementation data showed that various healthcare practitioners, including nurses and health educators, could effectively deliver the intervention, highlighting the importance of clinic administrator support for successful adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from field-testing a brief behavioral intervention package for African American women at risk for HIV/STDs. Jones, PL., Baker, JL., Gelaude, D., et al.[2022]

HIV prevention programs specifically designed for women have been shown to effectively reduce risky sexual behavior, with the most successful interventions focusing on relationship and negotiation skills, and involving sustained contact with participants.

The review of 47 studies highlights the need for female-controlled methods and the inclusion of heterosexual men in prevention strategies, suggesting that expanding options beyond male condoms can enhance women's ability to protect themselves against HIV and STDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of sexual risk behavior for HIV infection with women. Ehrhardt, AA., Exner, TM.[2007]

The peer group HIV prevention intervention significantly improved knowledge and attitudes about HIV and STDs among over 300 urban employed women in Botswana, demonstrating its efficacy in enhancing safer sex behaviors and confidence in condom use.

This intervention, based on social-cognitive learning theory, has proven to be sustainable, with peer group leaders continuing the program for over 5 years after funding ended, highlighting its low-cost and lasting impact on community health promotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of peer group education on HIV prevention among women in Botswana. Norr, KF., Norr, JL., McElmurry, BJ., et al.[2006]

A meta-analysis of 46 behavioral intervention studies in Asia found that these interventions consistently reduced sexual risk outcomes, such as increased condom use and decreased incidence of HIV and other sexually transmitted infections (STIs).

The effectiveness of these interventions was enhanced when they targeted more women, included motivational content, and provided STI counseling and testing, highlighting the importance of tailoring programs to specific populations and contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the efficacy of HIV/AIDS prevention interventions in Asia, 1995-2009. Tan, JY., Huedo-Medina, TB., Warren, MR., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Behavior change interventions to prevent HIV infection among women living in low and middle income countries: a systematic review. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an HIV prevention intervention designed for African American Women: results from the SISTA Community-Based Organization Behavioral Outcomes Project. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mediation analysis of an effective sexual risk-reduction intervention for women: the importance of self-efficacy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an evidence-based HIV prevention intervention when implemented by frontline providers. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a health educator-delivered HIV prevention intervention for Latina women: a randomized controlled trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Lessons learned from field-testing a brief behavioral intervention package for African American women at risk for HIV/STDs. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Prevention of sexual risk behavior for HIV infection with women. [2007]

9. England pubmed.ncbi.nlm.nih.gov

Impact of peer group education on HIV prevention among women in Botswana. [2006]

10. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of the efficacy of HIV/AIDS prevention interventions in Asia, 1995-2009. [2021]