Virtual Support Group for PrEP Use in HIV Prevention

(GODDESS Trial)

Overseen By Felicia A Browne, ScD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: RTI International

Disqualifiers: HIV positive, Previous study participation

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

500 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 mHealth-Women's CoOp, Virtual Group for PrEP use in HIV prevention?

Research shows that mobile apps can help increase the use of PrEP (a medication to prevent HIV) among people at risk, which suggests that virtual support groups might also improve PrEP uptake and adherence. ^{1 2 3 4 5}

Is the Virtual Support Group for PrEP Use in HIV Prevention safe for humans?

The research articles provided do not contain specific safety data for the Virtual Support Group for PrEP Use in HIV Prevention or related interventions like mHealth-Women's CoOp or Virtual Group. They focus on adherence and effectiveness rather than safety. ^{1 2 3 4 6}

How does the mHealth-Women's CoOp treatment differ from other treatments for HIV prevention?

The mHealth-Women's CoOp treatment is unique because it uses virtual support groups to enhance the use of PrEP (pre-exposure prophylaxis) among women, focusing on increasing access and adherence through mobile health technology, which is different from traditional methods that rely on in-person interactions or standard medical care. ^{1 5 7 8 9}

What is the purpose of this trial?

This trial tests a smartphone health app, with some people also joining online meetings. It targets young African American women who misuse alcohol and are HIV-negative. The app provides tracking and tips to reduce risky behaviors, while the meetings add peer support.

Research Team

Felicia A Browne, ScD, MPH

Principal Investigator

RTI International

Eligibility Criteria

This trial is for young African American women aged 18-30 who misuse alcohol, are HIV-negative, and not on PrEP. Participants must own a smartphone with Android or iOS. Women who have tested positive for HIV or participated in related studies can't join.

Inclusion Criteria

Have an Android or iOS-based smartphone

Identify as Black/African American

I identify as female.

Exclusion Criteria

Test positive for HIV

Participated in the previous study activities of the current study or previous related studies

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the mHealth app or the mHealth app plus the group component

6 months

App installation visit

Follow-up

Participants are monitored for biobehavioral outcomes including alcohol use, PrEP uptake, and sexual risk at 3- and 6-month intervals

6 months

Follow-up assessments at 3 and 6 months

Treatment Details

Interventions

• mHealth-Women's CoOp
• Virtual Group

Trial Overview The study compares two approaches: one group uses an mHealth app, while the other uses the mHealth app plus virtual group support. The aim is to see if adding group support helps reduce alcohol use, lowers sexual risk, and increases PrEP usage over a year.

Participant Groups

Group I: Enhanced: mHealth-Women's CoOp+Group Experimental Treatment 2 Interventions

Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young African American women, in addition to a virtual peer group component. The app with a link to the virtual group will be installed on each participant's smartphone by study staff after randomization.

Group II: Standard: mHealth-Women's CoOp Active Control 1 Intervention

Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young African American women. The app will be installed on each participant's smartphone by study staff after randomization.

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Recruited

942,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

An enhanced adherence support program (enPrEP) for oral PrEP did not significantly improve adherence rates among Black MSM and TGW, with only 30% adherence reported at 12 months.

Factors such as lower education levels and depressive symptoms were associated with lower adherence, highlighting the need for innovative strategies to improve PrEP adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pre-exposure Prophylaxis in Black Men Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY. Colson, PW., Franks, J., Wu, Y., et al.[2022]

In a randomized clinical trial involving 229 MSM participants, providing automated feedback through a mobile app did not reduce the number of participants with poor adherence to preexposure prophylaxis (PrEP), with 16% in the intervention group showing poor adherence compared to 11% in the control group.

However, the app feedback significantly increased the proportion of participants achieving excellent adherence (48% in the intervention group vs. 31% in the control group), indicating that while it didn't help those struggling with adherence, it did support those already adhering well to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. van den Elshout, MAM., Hoornenborg, E., Achterbergh, RCA., et al.[2023]

HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV, yet many eligible individuals are not receiving it, highlighting a gap in access to this important preventive measure.

Recommendations from PrEP Coordinators in San Francisco emphasize the need for better training, integration of PrEP into routine care, and proactive strategies to improve patient retention and communication, particularly for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. Shrestha, I., Ming, K., Jimenez, V., et al.[2023]

A systematic search identified only 11 out of 621 mobile apps that effectively support the uptake and adherence of PrEP, indicating a significant gap in available resources for at-risk individuals.

The evaluated apps showed moderate effectiveness in facilitating PrEP use by providing essential information and resources, and they received an acceptable quality rating, suggesting they could help increase PrEP uptake among those at risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. Sharpe, JD., Kamara, MT.[2019]

Oral HIV pre-exposure prophylaxis (PrEP) has been shown to effectively reduce HIV incidence among women who adhere to the treatment, but awareness and uptake remain low, particularly among women from racial and ethnic minority communities.

Innovative strategies, including the development of topical formulations and long-acting injectable PrEP, along with community-oriented approaches, are essential to improve access and adherence to PrEP, potentially making a significant impact on the HIV epidemic among women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis for HIV prevention in women: current perspectives. Flash, CA., Dale, SK., Krakower, DS.[2020]

A study involving 130 women showed that while most reported good adherence to PrEP, some admitted to over-reporting, indicating a need for better adherence support and education.

Many women expressed intentions not to use PrEP in the future due to perceived low personal risk and concerns about affordability, rather than side effects, highlighting the importance of addressing these barriers to improve PrEP uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of US women participating in a candidate PrEP study: adherence, acceptability and future use intentions. Amico, KR., Ramirez, C., Caplan, MR., et al.[2023]

References

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

Adherence to Pre-exposure Prophylaxis in Black Men Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. [2023]

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

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis for HIV prevention in women: current perspectives. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Perspectives of US women participating in a candidate PrEP study: adherence, acceptability and future use intentions. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Protocol for WeExPAnd: a prospective, mixed-methods pilot demonstration study to increase access to pre-exposure prophylaxis among women vulnerable to HIV infection in the Southern USA. [2023]

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

TransPrEP: Results from the Pilot Study of a Social Network-Based Intervention to Support PrEP Adherence Among Transgender Women in Lima, Peru. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Identifying Ethical and Culturally Responsive Research Activities to Build Trust and Improve Participation of Black Sexual Minority Men in Pre-Exposure Prophylaxis Telehealth Clinical Trials: Qualitative Study. [2022]