Women SHINE Intervention for HIV/AIDS

Overseen By Cassandra Cyr, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: ART

Disqualifiers: Transgender, No HIV, Cognitive impairment, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 5

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (\< 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone/text-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since participants must be currently prescribed ART (HIV medication), it seems you should continue taking it.

Is the Women SHINE Intervention safe for humans?

The research articles reviewed do not provide specific safety data for the Women SHINE Intervention or related peer navigation interventions, but they do not report any safety concerns either. ^{1 2 3 4 5}

How does the Women SHINE treatment for HIV/AIDS differ from other treatments?

The Women SHINE treatment is unique because it combines web-based trauma-informed peer navigation and social support to help women with HIV/AIDS who have experienced sexual trauma. This approach focuses on building coping skills and improving engagement with HIV care, which is different from standard treatments that primarily focus on medication adherence. ^{6 7 8 9 10}

What data supports the effectiveness of the Women SHINE Intervention for HIV/AIDS treatment?

Research shows that peer navigation, a key component of the Women SHINE Intervention, is effective in helping people with HIV engage in care and stick to their treatment. Studies in different settings have found that peer navigators can provide emotional support and help overcome barriers to care, which improves treatment outcomes. ^{1 2 3 11 12}

Who Is on the Research Team?

Jamila K Stockman, PhD, MPH

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for cisgender women over 18 living with HIV/AIDS who have experienced interpersonal violence as adults and are not fully adherent to their antiretroviral therapy (ART). Participants must speak English or Spanish, have internet access, and cannot be involved in another adherence intervention.

Inclusion Criteria

Self-report of <90% past-month ART adherence

Access to an internet browser

I identify as a cisgender female.

Exclusion Criteria

No access to an internet browser

I am a transgender female.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Women SHINE intervention arm receives a four-month program including video-based peer navigation support, 7 weekly psychoeducation support group sessions, and access to a static website with resources.

16 weeks

Weekly sessions (virtual)

Control

Control arm receives one 60-minute group session on self-care and well-being and access to a static website with resources.

1 week

1 session (virtual)

Follow-up

Participants are monitored for improvements in ART adherence, PTSD symptoms, and emotion regulation at 4-, 8-, and 12-months post-randomization.

12 months

Assessments at 4, 8, and 12 months (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Women SHINE

Trial Overview The study compares the Women SHINE web-based peer support program against a control group. The Women SHINE group receives one-on-one sessions, check-ins, support groups with therapists, and resource access. The control gets a single self-care session and similar resources.

How Is the Trial Designed?

Group I: Women SHINE Experimental Treatment 1 Intervention

Women SHINE consists of a four-month intervention that includes video-based one-on-one peer navigation and 7 weekly psycho-education support group sessions co-facilitated by a licensed clinical therapist (LCT) and peer navigator (PN). 180 women will be enrolled in the Women SHINE intervention and will remain in their assigned psycho-education support group sessions with the same members over the course of the intervention.

Group II: Control Arm Placebo Group 1 Intervention

Women assigned to the control arm (n=180) will receive one 60-minute group session facilitated by the licensed clinical therapist (LCT) on self-care and well-being as it relates to HIV, interpersonal violence, trauma, adverse mental health, and substance use. During this session, women will be provided with resources to HIV care, interpersonal violence, trauma, mental health, and substance use, through a static website created for Women SHINE. The content will include: 1) names and locations of clinics and organizations, services provided, and contact information; 2) links to support websites and hotlines and 3) testimonials from WLHA.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The Conexiones Saludables peer navigation intervention was found to be acceptable among Latinx key populations in Tijuana, Mexico, highlighting its potential effectiveness in improving engagement in the HIV care continuum.

Peer navigators played a crucial role in educating participants about HIV and antiretroviral therapy, linking them to care services, and providing emotional support, which is essential for overcoming sociostructural barriers faced by these vulnerable groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"He is the Same as Me": Key Populations' Acceptability and Experience of a Community-Based Peer Navigator Intervention to Support Engagement in HIV Care in Tijuana, Mexico. Rocha-Jiménez, T., Pitpitan, EV., Cazares, R., et al.[2023]

Peer navigation significantly improves the quality of HIV care for female sex workers (FSWs), as evidenced by a study of 211 participants in the Dominican Republic, where 41.2% reported contact with a peer navigator in the last 6 months.

FSWs who engaged with peer navigators experienced more respectful treatment from clinic staff and reported greater satisfaction with their overall HIV care services, highlighting the importance of peer support in enhancing healthcare experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring peer navigation and support in the quality of HIV care experiences of female sex workers in the Dominican Republic. Karver, TS., Barrington, C., Donastorg, Y., et al.[2022]

Peer navigation programs for people living with HIV have shown positive effects on the continuum of care outcomes, as evidenced by a review of various study designs including randomized control trials and qualitative studies.

Further research is needed to better understand the specific roles of peer navigators in improving health outcomes, mental health, and self-management for individuals with HIV, highlighting the complexity and social nature of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects. Krulic, T., Brown, G., Bourne, A.[2022]

The MAPPS training program successfully trained HIV-positive peer mentors to effectively deliver a comprehensive behavioral change intervention aimed at increasing engagement in HIV care, demonstrating both feasibility and effectiveness.

Mentors rated the training program highly, and objective assessments showed they could meet the necessary standards for intervention fidelity, indicating that peer-led approaches can be a valuable strategy in promoting patient self-care in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of a standardized training program for a patient-mentoring intervention to increase adherence to outpatient HIV care. Cully, JA., Mignogna, J., Stanley, MA., et al.[2021]

A peer navigation program was piloted in South Africa with 25 newly diagnosed HIV-positive clients, showing high acceptability and satisfaction, which suggests it could effectively enhance engagement in HIV care and ART adherence.

The program addressed significant barriers like HIV stigma by providing education and support, helping clients overcome shame and fears of discrimination, ultimately facilitating better care engagement and prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging HIV-positive clients in care: acceptability and mechanisms of action of a peer navigation program in South Africa. Steward, WT., Sumitani, J., Moran, ME., et al.[2019]

The 'Salud y Orgullo Mexicano' (SOM) intervention was specifically designed to improve HIV care linkage and retention for Mexican men who have sex with men (MSM) in Chicago, utilizing community input and a modified intervention mapping process.

The development of SOM involved combining elements from existing interventions and refining them based on feedback from the target community, with plans for future implementation and evaluation to assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salud y Orgullo Mexicano: Development of a Culturally Specific Transnational Linkage and Retention in Care Intervention for Mexican Men Who Have Sex with Men Living with HIV in Chicago. Johnson, AK., Buenrostro, R., Soberanis, G., et al.[2021]

A scoping review of 18 studies on peer-led HIV behavioral interventions revealed significant variability in training strategies, with 11 studies using manualized training materials and 9 incorporating role-play, indicating diverse approaches to preparing peer health workers.

To enhance the effectiveness and sustainability of peer engagement in HIV care, there is a need for a consensus on best training practices among researchers, as current methods lack standardization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in U.S. HIV Peer Health Worker Training Strategies and Approaches: A Scoping Review of the Literature. Gormley, M., Loughran, C., Conte, J., et al.[2023]

The study will evaluate the effectiveness of the ImpACT+ intervention, a trauma-focused coping strategy, in promoting viral suppression and ART adherence among 350 women living with HIV initiating treatment in South Africa.

By addressing the mental health impacts of sexual trauma, the ImpACT+ intervention aims to improve clinical outcomes and overall well-being for women, potentially leading to significant benefits for communities in sub-Saharan Africa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ImpACT+, a coping intervention to improve clinical outcomes for women living with HIV and sexual trauma in South Africa: study protocol for a randomized controlled trial. Sikkema, KJ., Rabie, S., King, A., et al.[2023]

The ImpACT intervention, tested in a pilot trial with 64 HIV-infected women in Cape Town, showed promise in reducing PTSD symptoms and increasing motivation to adhere to antiretroviral medications (ARVs).

Participants reported significant improvements in coping with trauma, enhanced confidence, and better interpersonal relationships, indicating that the intervention effectively supports long-term HIV care engagement despite challenges like social isolation and logistical barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's perspectives on ImpACT: a coping intervention to address sexual trauma and improve HIV care engagement in Cape Town, South Africa. Knettel, BA., Mulawa, MI., Knippler, ET., et al.[2020]

The ImpACT intervention effectively helped a 34-year-old woman with a history of sexual trauma and HIV improve her coping skills, reduce alcohol use, and maintain strong engagement in HIV care, demonstrating its potential in resource-limited settings.

The case highlights the importance of addressing personal values and barriers to care in therapy, as well as the emotional challenges faced by counselors working with traumatized individuals, which can inform future therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I cannot change what happened to me, but I can learn to change how I feel": A case study from ImpACT, an intervention for women with a history of sexual trauma who are living with HIV in Cape Town, South Africa. Knettel, BA., Robertson, C., Ciya, N., et al.[2023]

Trauma, particularly the death of family members and partners, is a significant catalyst for drug use among women who use drugs and are living with HIV (WWUDHIV) in Dar es Salaam, Tanzania, highlighting the need for trauma-informed care in interventions.

The study reveals that traumatic experiences are cumulative and often lead to poor mental health, increased drug use, and vulnerability to HIV, suggesting that targeted interventions during critical life events, such as HIV diagnosis or pregnancy, could help mitigate these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From trauma to transmission: exploring the intersection of adversity, substance use, and HIV risk in women's life histories. West, NS., Kussaga, F., Rittenhouse, A., et al.[2023]

Women join vaginal microbicide trials for reasons like healthcare access and financial reimbursement, but fear of adverse effects from the product significantly impacts their adherence to using the gel.

Participants suggested improvements for trial design, such as testing applicators and providing real-time feedback, to enhance adherence and ensure accurate reporting of gel use, highlighting the importance of understanding participants' perspectives in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women design their own vaginal microbicide trial: Suggestions on how to improve adherence from former participants of HIV prevention trials. Miller, L., Morar, N., Kapiga, S., et al.[2023]

Citations

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

"He is the Same as Me": Key Populations' Acceptability and Experience of a Community-Based Peer Navigator Intervention to Support Engagement in HIV Care in Tijuana, Mexico. [2023]

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

Exploring peer navigation and support in the quality of HIV care experiences of female sex workers in the Dominican Republic. [2022]

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

A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects. [2022]

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

Development and pilot testing of a standardized training program for a patient-mentoring intervention to increase adherence to outpatient HIV care. [2021]

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

Engaging HIV-positive clients in care: acceptability and mechanisms of action of a peer navigation program in South Africa. [2019]

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

Salud y Orgullo Mexicano: Development of a Culturally Specific Transnational Linkage and Retention in Care Intervention for Mexican Men Who Have Sex with Men Living with HIV in Chicago. [2021]

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

Trends in U.S. HIV Peer Health Worker Training Strategies and Approaches: A Scoping Review of the Literature. [2023]

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

ImpACT+, a coping intervention to improve clinical outcomes for women living with HIV and sexual trauma in South Africa: study protocol for a randomized controlled trial. [2023]

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

Women's perspectives on ImpACT: a coping intervention to address sexual trauma and improve HIV care engagement in Cape Town, South Africa. [2020]

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

"I cannot change what happened to me, but I can learn to change how I feel": A case study from ImpACT, an intervention for women with a history of sexual trauma who are living with HIV in Cape Town, South Africa. [2023]

11. England pubmed.ncbi.nlm.nih.gov

From trauma to transmission: exploring the intersection of adversity, substance use, and HIV risk in women's life histories. [2023]

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

Women design their own vaginal microbicide trial: Suggestions on how to improve adherence from former participants of HIV prevention trials. [2023]