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

HIV Clinical Trial

— PeerCARE  

Official title:

The PeerCARE Study (Peer Community-based Assistant in REtention): Effect of Peer Health Workers on People Living With HIV Not on Antiretroviral Therapy—A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366690
• Other study ID #: NA_00040431
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: September 8, 2014
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria: See above.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Peer Support
A trained peer supporter is assigned to support newly HIV-positive diagnosed persons.

Locations

Country	Name	City	State
Uganda	Rakai Health Sciences Program	Entebee

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Rakai Health Sciences Program

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement in Care		1 Year	No
Primary	Basic Care Package Adherence	Adherence to a basic care package of preventive care interventions (bednets, water vessels, cotrimoxazole)	1 Year	No
Primary	Condom Use	Consistent, inconsistent, or never condom use.	1 Year	No
Secondary	ART Use		1 Year	No