ADELANTE for HIV

Recruiting at 1 trial location

Overseen By Julie H Levison, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Antiretrovirals

Disqualifiers: Lacks consent capacity, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

250 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. It seems focused on a behavioral intervention rather than medication changes.

What data supports the effectiveness of the ADELANTE treatment for HIV?

Research shows that community health worker interventions, a key part of the ADELANTE treatment, are effective in improving health outcomes for people living with HIV by increasing retention in care and helping with viral suppression. ^{1 2 3 4 5}

Is the ADELANTE intervention generally safe for humans?

The ADELANTE intervention, delivered by community health workers, has been used in various studies to support people living with HIV. While these studies focus on improving health outcomes, they do not report any specific safety concerns related to the intervention itself. ^{3 6 7 8 9}

How is the ADELANTE treatment for HIV different from other treatments?

The ADELANTE treatment is unique because it involves community health workers (CHWs) delivering a problem-solving intervention to help people with HIV, focusing on increasing retention in care and improving viral suppression, especially in racial/ethnic minority communities. This approach is different from standard medical treatments as it emphasizes community-based support and counseling rather than just medication. ^{2 8 10 11 12}

What is the purpose of this trial?

The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization.

Eligibility Criteria

This trial is for Latinos with HIV who are struggling to keep the virus under control. Participants will be randomly assigned to receive either a new intervention called ADELANTE, which includes five sessions with a community health worker, or an enhanced care condition involving five reminder phone calls.

Inclusion Criteria

Confirmed HIV infection by standard laboratory results

Medical record evidence with last viral load (VL) indicating viral non-suppression (HIV RNA ≥200 cpm) within 90 days of assessment of eligibility

Receiving HIV primary care at Jackson Memorial Hospital or Thomas Street at Quentin Mease Health Center/Harris Health System

Exclusion Criteria

I am unable to understand and make decisions about my treatment.

Currently participating in an HIV intervention study with ongoing follow-up

Plans to move out of the county in the next 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive 5 individualized problem-solving sessions delivered by a community health worker over 6 months, framed around a bi-lingual film about HIV

6 months

5 sessions (in-person or virtual)

Enhanced Care Condition

Participants receive 5 locator phone calls confirming contact information and routine HIV health promotion materials

6 months

5 phone calls

Follow-up

Participants are monitored for viral suppression, emergency room visits, and hospitalizations

12 months

Assessments at baseline, month-3, month-6, and month-12

Treatment Details

Interventions

• ADELANTE

Trial Overview The study aims to see if ADELANTE can help participants better manage their HIV and achieve viral suppression compared to those receiving just reminder calls. The success of the program will be measured by checking rates of viral suppression and tracking emergency room visits and hospitalizations over a year.

Participant Groups

Group I: ADELANTE Experimental Treatment 1 Intervention

Participants will receive 5, individualized problem solving sessions delivered by a community health worker over 6 months. The intervention content is framed around a bi-lingual film about HIV.

Group II: Enhanced Care Condition Active Control 1 Intervention

Participants in the enhanced care control group will receive 5 locator phone calls confirming contact information at the same interval as CHW sessions in the ADELANTE group. They will be offered routine HIV health promotion materials as is available in the clinic. If a participant requests support for navigation or case management, they will be encouraged to contact their HIV team

ADELANTE is already approved in United States for the following indications:

Approved in United States as ADELANTE for:

• Improving engagement in care for Latinos with HIV and viral non-suppression

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Findings from Research

Indigenous outreach workers have been effective in reducing HIV risk behaviors and promoting preventive actions among injection drug users (IDUs), contributing to a decrease in HIV seroincidence in various cities.

The study highlights the evolving role of outreach workers as case managers, emphasizing their importance in addressing the complex needs of IDUs and improving their health and living conditions through tailored support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stories of AIDS outreach and case management: context and activities. Rahimian, A., Pach, A.[2019]

Community health workers (CHWs) play a crucial role in improving care retention and viral suppression for people living with HIV, but their effectiveness is hindered by unclear roles, inadequate funding, and limited training opportunities.

Key factors for successful CHW integration include establishing standardized roles, fostering interorganizational networks, and providing comprehensive training in areas like trauma-informed care and cultural humility, which can enhance their impact on HIV care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Implementation Science to Promote Integration and Sustainability of Community Health Workers in the HIV Workforce. Rajabiun, S., Killion, K., Lennon-Dearing, R., et al.[2023]

Community health worker (CHW) interventions show promise in improving psychosocial outcomes for people living with HIV, particularly in areas like quality of life and self-efficacy, based on a review of 14 randomized controlled trials.

However, these interventions have not been effective in reducing depressive symptoms or stigma related to HIV, indicating a need for future studies to expand their focus and incorporate measures of intervention fidelity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health worker interventions to promote psychosocial outcomes among people living with HIV-A systematic review. Han, HR., Kim, K., Murphy, J., et al.[2019]

Zanmi Lasante (ZL) has significantly contributed to HIV prevention and treatment in Haiti by utilizing community health workers (CHWs) to enhance access to healthcare services, particularly in rural areas with limited infrastructure.

The study found that CHWs effectively identify at-risk patients and facilitate the uptake of primary healthcare services among vulnerable populations, highlighting the importance of community engagement in improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers as a cornerstone for integrating HIV and primary healthcare. Mukherjee, JS., Eustache, FE.[2022]

In a study of 204 people with HIV, factors such as being female, having marginal health literacy, or a substance use disorder were linked to lower satisfaction with community health workers (CHWs), highlighting the need for tailored support.

Conversely, clients who were housed and had a mental health diagnosis reported higher satisfaction, suggesting that addressing social determinants of health is crucial for improving CHW service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client Satisfaction with Community Health Workers in HIV Care Teams. Wolfe, HL., Baughman, A., Davoust, M., et al.[2021]

Community healthcare workers (CHWs) play a crucial role in enhancing HIV services in sub-Saharan Africa by providing support and education, which can improve adherence to treatment and promote safe practices.

This meta-synthesis aims to identify barriers and facilitators affecting CHWs' ability to deliver HIV services, using qualitative evidence from studies conducted between 2009 and 2019, which will help optimize their effectiveness in the region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators of rendering HIV services by community health workers in sub-Saharan Africa: a meta-synthesis protocol. Khumalo, GE., Lutge, E., Naidoo, P., et al.[2021]

In a study involving 1,799 HIV-positive patients in Ethiopia, community support workers provided education and counseling, but the intervention did not significantly reduce gaps in clinical care or mortality over 36 months.

Factors such as HIV stigma and political instability may have limited the effectiveness of the community support worker intervention, highlighting the importance of considering local context in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A three-year randomized community trial of community support workers in rural Ethiopia to promote retention in HIV care. Lifson, AR., Hailemichael, A., Workneh, S., et al.[2023]

A study involving 91 African-American individuals living with HIV showed that those receiving support from community health workers (CHWs) had a significantly lower HIV viral load after 12 months compared to those who did not receive this intervention.

While the intervention improved viral load, there was no significant difference in CD4 cell counts between the two groups, suggesting that CHWs may be effective in managing viral load but further research is needed to assess their overall impact on HIV treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using community health workers to improve clinical outcomes among people living with HIV: a randomized controlled trial. Kenya, S., Jones, J., Arheart, K., et al.[2022]

In a study of 80 individuals starting HIV care in Tanzania, most reported good adherence to antiretroviral therapy (ART) and recognized its benefits, but many also experienced high levels of depression and anxiety.

Despite the potential role of community health workers (CHWs) in supporting patients, their involvement was low, and meeting with a CHW did not lead to improved medication adherence, highlighting a missed opportunity to better support patients facing mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Influence of Community Health Worker Support on Early Antiretroviral Therapy Adherence, Anticipated Stigma, and Mental Health Among People Living with HIV in Tanzania. Knettel, BA., Wanda, L., Amiri, I., et al.[2022]

A community randomized trial in southern Ethiopia enrolled 1799 adults newly entering HIV care to assess the effectiveness of community health workers (CHWs) in improving retention in HIV treatment.

The trial faced challenges such as a shortage of HIV test kits and issues like stigma and distance, but successfully implemented a support system through 71 trained CHWs who provided education, counseling, and facilitated communication with clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation. Lifson, AR., Workneh, S., Hailemichael, A., et al.[2019]

The HPTN 071 (PopART) trial demonstrated that 737 community-based health workers (CHWs) effectively delivered a comprehensive door-to-door HIV prevention package in Zambia and South Africa, showing good fidelity to the intervention despite initial challenges in service quality and retention.

Key factors for the successful implementation of the CHW model included thorough training, emotional support, monitoring, and fair remuneration, suggesting that these elements are crucial for transferring similar interventions to other regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based health workers implementing universal access to HIV testing and treatment: lessons from South Africa and Zambia-HPTN 071 (PopART). Viljoen, L., Mainga, T., Casper, R., et al.[2022]

A structured risk-reduction intervention delivered by community health workers to 634 people living with HIV in Mombasa, Kenya, significantly reduced risky sexual behaviors and increased the uptake of antiretroviral therapy (ART) among participants.

Participants in the intervention group reported a dramatic decrease in unprotected sex acts (12.3% vs. 46.0% in the control group) and a higher percentage of ART uptake (34.3% vs. 12.7%), demonstrating the effectiveness of community health workers in reaching and supporting hard-to-reach populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a community-based positive prevention intervention for people living with HIV who are not receiving antiretroviral treatment: a prospective cohort study. Sarna, A., Luchters, S., Musenge, E., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Stories of AIDS outreach and case management: context and activities. [2019]

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

Using Implementation Science to Promote Integration and Sustainability of Community Health Workers in the HIV Workforce. [2023]

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

Community health worker interventions to promote psychosocial outcomes among people living with HIV-A systematic review. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Community health workers as a cornerstone for integrating HIV and primary healthcare. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Client Satisfaction with Community Health Workers in HIV Care Teams. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Barriers and facilitators of rendering HIV services by community health workers in sub-Saharan Africa: a meta-synthesis protocol. [2021]

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

A three-year randomized community trial of community support workers in rural Ethiopia to promote retention in HIV care. [2023]

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

Using community health workers to improve clinical outcomes among people living with HIV: a randomized controlled trial. [2022]

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

Assessing the Influence of Community Health Worker Support on Early Antiretroviral Therapy Adherence, Anticipated Stigma, and Mental Health Among People Living with HIV in Tanzania. [2022]

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

A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation. [2019]

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

Community-based health workers implementing universal access to HIV testing and treatment: lessons from South Africa and Zambia-HPTN 071 (PopART). [2022]

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

Effectiveness of a community-based positive prevention intervention for people living with HIV who are not receiving antiretroviral treatment: a prospective cohort study. [2021]