The PeerCARE Study (Peer Community-based Assistant in REtention)

NCT01366690 | Completed

• 1 other identifier: NA_00040431
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The provision of HIV care and prevention services in resource-limited settings (RLS) entails substantial challenges due to a human resource crisis.\[1\] One strategy to address this human resource crisis is task shifting-the redistribution of tasks from higher trained providers to health workers with less training. Peer supporters, a group of community health workers who are people living with HIV (PLHIV), are an underutilized cadre to whom tasks can be shifted. Peers have been used extensively and effectively in HIV/AIDS programs in RLS, typically as peer educators who provide HIV prevention and education services.\[2\] Peers may be a potential source for not only providing care, but also impacting patient behaviors through peer counseling, education, and psychosocial support. With the scale up of HIV counseling and testing in RLS, increasing numbers of PLHIV know their serostatus and could potentially be engaged in care and prevention services. While antiretroviral therapy (ART) is a critical component of care which has been a source of much attention, PLHIV who are not yet on ART can also benefit from being engaged in care and utilizing other evidence-based health interventions besides ART. Also, many HIV/AIDS care programs have difficulty both retaining PLHIV in care prior to ART and initiating ART in a timely fashion. Additionally, many PLHIV not yet on ART still engage in risky sexual behaviors and do not fully utilize a proven basic preventive care package (BCP) set of interventions (cotrimoxazole prophylaxis, bed nets, and safe water systems). Peers may be able to impact PLHIV not yet on ART by improving linkages to care, facilitating timely initiation of preventive interventions and ART, and decreasing risky sexual behaviors. However, well-designed and evaluated operations research is needed to assess peer support effects on these care and behavioral outcomes. The objective of this study is to assess the impact of a peer support home visit intervention on patient engagement in care, utilization of a basic care package (BCP) of preventive care interventions, and risky sexual behaviors among people living with HIV (PLHIV) not on antiretroviral therapy (ART) through an individually randomized, operations research, community-based trial. We will compare outcomes between PLHIV who receive the peer-led intervention to those who do not. The primary outcomes will be engagement in care, BCP adherence, and condom use. The study hypotheses are as follows: (1) PLHIV who receive the peer intervention will have improved engagement in care compared to PLHIV not receiving the intervention; (2) PLHIV who receive the peer intervention are more likely to adhere to a BCP of interventions to prevent illness compared to PLHIV not receiving the intervention; (3) PLHIV who receive the peer intervention will have less risky sexual behaviors compared to PLHIV not receiving the intervention.

Conditions

HIV

Keywords

HIV; community health workers; randomized trial; task shifting; Uganda; retention; operations research; implementation research

Outcome Measures

Primary Outcomes (3)

• Engagement in Care

  1 Year

• Basic Care Package Adherence

  Adherence to a basic care package of preventive care interventions (bednets, water vessels, cotrimoxazole)

  1 Year

• Condom Use

  Consistent, inconsistent, or never condom use.

  1 Year

Secondary Outcomes (1)

• ART Use

  1 Year

Study Arms (2)

Peer Support

EXPERIMENTAL

Peer supporter assigned to participant.

Behavioral: Peer Support

Standard of Care

NO INTERVENTION

No peer assigned. Current standard of care.

Interventions

Peer Support BEHAVIORAL

A trained peer supporter is assigned to support newly HIV-positive diagnosed persons.

Peer Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly found to be HIV-infected through Rakai Health Sciences Program (RHSP) testing
• Agreed to receive HIV results
• Able to give consent for this study
• Age 18 years or greater

Sponsors & Collaborators

• Johns Hopkins University: lead
• Rakai Health Sciences Program: collaborator

Study Sites (1)

Rakai Health Sciences Program

Entebee, Uganda

Location

Related Publications (1)

• Monroe A, Nakigozi G, Ddaaki W, Bazaale JM, Gray RH, Wawer MJ, Reynolds SJ, Kennedy CE, Chang LW. Qualitative insights into implementation, processes, and outcomes of a randomized trial on peer support and HIV care engagement in Rakai, Uganda. BMC Infect Dis. 2017 Jan 10;17(1):54. doi: 10.1186/s12879-016-2156-0.

  PMID: 28068935 DERIVED

Study Officials

• Larry William Chang, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: June 1, 2014
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

UG (1)