Group vs Individual Interventions for HIV Prevention

Recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective way to help African-born Black women in the US prevent HIV through two adapted programs. These programs, DADA and Dada Kwa Dada, focus on increasing condom use and promoting PrEP (a medication that helps prevent HIV). Participants will join either virtual one-on-one sessions or group sessions to determine which approach is more effective. Women who are HIV-negative, born in an African country, living in the Greater Boston Area or New York City, and have had recent unprotected sex may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance HIV prevention strategies for African-born Black women.

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 prior data suggests that these interventions are safe for African-born women?

Research has shown that the SISTA program, on which DADA is based, has been used widely to educate women about HIV prevention. Studies indicate it is generally well-received, with few reports of negative side effects. Cultural adjustments to SISTA have also proven effective, suggesting it is safe for participants.

For Dada Kwa Dada, adapted from another proven program, no direct evidence of harmful effects exists. Like DADA, it focuses on education and behavior change, which typically carry a low risk of harm. Since both programs rely on established methods that teach safe practices, they are expected to be well-received by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for HIV prevention because they explore new ways to deliver education and support. Unlike traditional in-person sessions, these interventions use virtual platforms, making them more accessible and flexible for participants. The individual-level intervention offers personalized one-on-one virtual sessions, allowing for tailored guidance. Meanwhile, the group-level intervention provides a dynamic environment through virtual group sessions, encouraging peer interaction and shared learning. These innovative approaches aim to enhance engagement and effectiveness in preventing HIV.

What evidence suggests that this trial's interventions could be effective for HIV prevention?

Research has shown that the SISTA program, on which DADA is based, has increased condom use among African American women. Studies have found that SISTA is culturally relevant and improves behaviors that prevent HIV. In this trial, participants may receive the DADA intervention through virtual group sessions. Similarly, the Sister to Sister (S2S) program, from which Dada Kwa Dada (DKD) is adapted, has successfully encouraged safer sexual practices. Participants in this trial may receive the DKD intervention through virtual one-on-one sessions. These programs have been customized to fit the cultural needs of African-born women, aiming to increase both condom use and the use of pre-exposure prophylaxis (PrEP). Early findings suggest these adapted programs show promise in effectively preventing HIV. ^{1 2 3 6 7}

Who Is on the Research Team?

Bisola O. Ojikutu, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Gray M. Maganga, MS

Principal Investigator

Brigham and Women's Hospital

Laura Bogart, PhD

Principal Investigator

RAND Corporation Inc

Khady Diouf, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22990762/

Evaluation of an HIV prevention intervention designed for ... ... HIV prevention behavioral interventions designed for African Americans. One such intervention is Sisters Informing Sisters about Topics on AIDS (SISTA), a ...

2. stacks.cdc.gov stacks.cdc.gov/view/cdc/147660

Evaluation of an HIV Prevention Intervention Designed for ... One such intervention is Sisters Informing Sisters about Topics on AIDS (SISTA), a culturally relevant and gender-specific, five-session, group-level, HIV ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06307028

Study Details | NCT06307028 | Sistas Informing Sistas on ... Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P) (SISTA-P). ClinicalTrials.gov ID NCT06307028. Sponsor Rutgers, The State University of ...

4. tandfonline.com tandfonline.com/doi/abs/10.1080/15381500802529822

The Role of Drug Education: Journal of HIV/AIDS & Social ... This study evaluated the effectiveness of the Sisters Informing Sisters about Topics on AIDS (SISTA) curriculum against an enhanced SISTA ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6248864/

Effectiveness of an evidence-based HIV prevention ... We evaluated Sisters Informing Sisters on Topics about AIDS (SISTA), an HIV ... SISTA Community-based organization behavioral outcomes ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18160376/

The SISTA pilot project: understanding the training and ... The Centers for Disease Control and Prevention (CDC) conducted a pilot project to disseminate the Sisters Informing Sisters about Topics on AIDS (SISTA), an HIV ...

7. researchwithrutgers.com researchwithrutgers.com/en/projects/sisters-informing-sisters-about-topics-on-aids-and-prevention-sis

Adaptation of the SISTA intervention to include PrEP ... I propose to adapt Sisters Informing Sisters about Topics on AIDS (SISTA), a widely implemented gender- and culture specific HIV prevention EBI. SISTA is a ...