Group vs Individual Interventions for HIV Prevention

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Bisola O. Ojikutu, MD, MPH

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

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

No Placebo Group

Trial Summary

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.

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.

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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.

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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.

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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

I am fluent in English or French.

HIV-negative

I am between 18 and 45 years old.

Exclusion Criteria

I am a cisgender man.

I am a transgender man.

Pregnant woman

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Muslim Women's Insitute for Research and Development Bronx, NY

Whittier Street Health Center Roxbury, MA

Brigham and Women's Hospital Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital Lead Sponsor

Patient-Centered Outcomes Research Institute Collaborator

Boston University Collaborator

RAND Collaborator

The Fenway Institute Collaborator

Whittier Street Health Center Collaborator

Muslim Women's Institute for Research and Development Collaborator

Harvard Street Neighborhood Health Center Collaborator

Harvard Medical School (HMS and HSDM) Collaborator

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] The disproportionate rates of HIV/AIDS among African American women in the U.S. signify the ongoing need for targeted HIV prevention interventions. Additionally, building the capacity of service providers to sustain prevention efforts is a major concern. 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 prevention intervention designed for African American women. The project was to inform the diffusion process and examine the training and technical assistance needs of participating community-based organizations. Results demonstrated a need for extensive pre-planning and skills-building prior to implementation.

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] We conducted a systematic review of behavioral change interventions to prevent the sexual transmission of HIV among women and girls living in low- and middle-income countries. PubMed/MEDLINE, Web of Science, the Cochrane Library, and other databases and bibliographies were systematically searched for trials using randomized or quasi-experimental designs to evaluate behavioral interventions with HIV infection as an outcome. We identified 11 analyses for inclusion reporting on eight unique interventions. Interventions varied widely in intensity, duration, and delivery as well as by target population. Only two analyses showed a significant protective effect on HIV incidence among women and only three of ten analyses that measured behavioral outcomes reduced any measure of HIV-related risk behavior. Ongoing research is needed to determine whether behavior change interventions can be incorporated as independent efficacious components in HIV prevention packages for women or simply as complements to biomedical prevention strategies.

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] One of the Centers for Disease Control and Prevention's strategies for addressing racial disparities within the HIV epidemic is to support the implementation of HIV prevention behavioral interventions designed for African Americans. One such intervention is Sisters Informing Sisters about Topics on AIDS (SISTA), a culturally relevant and gender-specific, five-session, group-level, HIV prevention intervention designed for African American women. In 2008, the Centers for Disease Control and Prevention funded five community-based organizations to conduct outcome monitoring of SISTA to assess the outcomes associated with implementation in the field. Using a 90-day recall, demographic and sexual risk data were collected from participants at baseline and at 90 and 180 days post-intervention. Findings reveal that women participating in SISTA (n = 432) demonstrated a significant reduction in sexual risk between baseline and both follow-up time points for each of the six outcomes being measured (e.g., any unprotected sex, all protected sex).

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] Sister-to-Sister: The Black Women's Health Project is a skill-building HIV/STD risk-reduction intervention for African American women that had significant effects in reducing self-reported sexual risk behavior and biologically confirmed sexually transmitted disease (STD) incidence. The present analyses were conducted to identify which theory-based factors that were addressed in the intervention accounted for its success.

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

Effectiveness of an evidence-based HIV prevention intervention when implemented by frontline providers. [2023] Carefully conducted randomized trials have established that sexual behavior change interventions can significantly reduce intervention participants' risk of acquiring HIV. Establishing the effectiveness of these evidence-based interventions when implemented by frontline HIV prevention service providers is increasingly important in order to achieve maximum public health impact. This study sought to assess the effectiveness of an evidence-based intervention when implemented by frontline HIV prevention service providers. We evaluated Sisters Informing Sisters on Topics about AIDS (SISTA), an HIV prevention intervention for heterosexual African American women, as implemented by four AIDS service organizations. Women enrolled in HIV counseling, testing, and referral (CTR) at each agency served as contemporaneous controls. Measures included self-reported number of occasions of unprotected vaginal intercourse and number of vaginal sex partners in the previous 90 days. 1,262 participants completed baseline and follow-up assessments across both conditions (SISTA = 537 [57%]; CTR = 725 [62%]). In the full sample of HIV-negative women, CTR participants' odds of having had unprotected sex decreased over time by 38% while SISTA participants' odds of having had unprotected sex did not change. Similar results were found among only those participants who had sex at baseline. Hypothesized interaction effects indicating positive changes in sexual risks over time for SISTA participants were not observed.

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] We developed and assessed AMIGAS (Amigas, Mujeres Latinas, Inform andonos, Gui andonos, y Apoy andonos contra el SIDA [friends, Latina women, informing each other, guiding each other, and supporting each other against AIDS]), a culturally congruent HIV prevention intervention for Latina women adapted from SiSTA (Sistas Informing Sistas about Topics on AIDS), an intervention for African American women.

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] This article describes how Sister to Sister, an evidence-based HIV/STD intervention for African American women in clinical settings, was prepared for national dissemination using the Centers for Disease Control and Prevention's Replicating Effective Programs research translation process. To test the feasibility of the intervention in the "real world," Sister to Sister's original research team collaborated with community partners to field-test the intervention in three clinical settings. Experiences from field-testing and input from a community advisory board were used to translate research protocols into a package of user-friendly materials that could be easily adopted by frontline clinic staff throughout the nation. Process monitoring and evaluation data demonstrated that Sister to Sister could be implemented successfully by a variety of practitioners including nurses, health educators, and HIV test counselors. "Buy-in" from clinic administrators and providers was a prerequisite to the success of the intervention. Replicating Effective Programs provided a useful process that can be applied by others to successfully prepare evidence-based interventions such as Sister to Sister for national dissemination.

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

Prevention of sexual risk behavior for HIV infection with women. [2007] This paper defines the components of gender-specific interventions for HIV infections for women, i.e. negotiation skills with male partners for condom use, integration of strategies against HIV and other STD infections and for contraception, the urgent need for female controlled methods, the importance of the inclusion of heterosexual men and an expansion to couples in prevention programs. This paper also presents a critical update in HIV prevention articles for women since the beginning of the AIDS epidemic through March 1996. All reviewed interventions were conducted in the U.S., Canada or Puerto Rico and described a psychological, behavioral, or educational component that addressed sexual risk reduction and included a behavioral evaluation. Manual and computer searches identified 47 studies that targeted women and provided a female-specific analysis of intervention effects. Overall, the findings demonstrate that HIV prevention programs can be effective in reducing risky sexual behavior among women. Program effectiveness varied by intervention type, session duration, and whether studies included women alone or both men and women. The most efficacious HIV prevention programs were specifically directed toward women, focused on relationship and negotiation skills, and involved multiple, sustained contacts. Evidence also indicated that community-level interventions hold promise. It is recommended that outcomes for women be expanded to include strategies beyond the male condom, such as refusing or avoiding unsafe sex or using the female condom.

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

Impact of peer group education on HIV prevention among women in Botswana. [2006] A peer group HIV prevention intervention based on social-cognitive learning theory, gender inequality, and the primary health care model for community-based health promotion was developed for more than 300 urban employed women in Botswana. All women volunteered to participate in the intervention. To control for self-selection, matched workplaces were assigned to the intervention group or to the delayed control group. Compared with women in the delayed control group, women in the intervention group had significantly higher postintervention levels of knowledge of HIV transmission, sexually transmitted diseases (STDs), and HIV prevention behaviors; positive condom attitudes and confidence in condom use; personal safer sex behaviors; and positive attitudes toward persons living with HIV/AIDS and community HIV/AIDS-related activities. The peer group leaders have sustained the program for more than 5 years after the end of research funding. Peer groups are a low-cost and sustainable intervention that can change HIV prevention knowledge, attitudes, and behaviors for ordinary urban employed women in sub-Saharan Africa.

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

A meta-analysis of the efficacy of HIV/AIDS prevention interventions in Asia, 1995-2009. [2021] The HIV/AIDS epidemic continues to grow in pockets across Asia, despite early successes at curtailing its spread in countries like Thailand. Recent evidence documents dramatic increases in incidence among risk groups and, alarmingly, the general population. This meta-analysis summarizes the sexual risk-reduction interventions for the prevention of HIV-infection that have been evaluated in Asia. Sexual risk-reduction outcomes (condom use, number of sexual partners, incident sexually transmitted infections [STI], including HIV) from 46 behavioral intervention studies with a comparison condition and available by August 2010 were included. Overall, behavioral interventions in Asia consistently reduced sexual risk outcomes. Condom use improved when interventions sampled more women, included motivational content, or did not include STI testing and treatment. Incident HIV/STI efficacy improved most when interventions sampled more women, were conducted more recently, or when they included STI counseling and testing. Sexual frequency efficacy improved more in interventions that were conducted in countries with lower human development capacities, when younger individuals were sampled, or when condom skills training was included. Behavioral interventions for reducing sexual risk in Asia are efficacious; yet, the magnitude of the effects co-varies with specific intervention and structural components. The impact of structural factors on HIV intervention efficacy must be considered when implementing and evaluating behavioral interventions. Implications and recommendations for HIV/AIDS interventions are discussed.