The PeerCARE Study (Peer Community-based Assistant in REtention)
Recruitment status was Recruiting
The provision of HIV care and prevention services in resource-limited settings (RLS) entails substantial challenges due to a human resource crisis. 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 heath workers (PHWs), 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. PHWs 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, bednets, and safe water systems). PHWs 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 PHW effects on these care and behavioral outcomes.
The objective of this study is to assess the impact of a peer health worker (PHW) home visit intervention on patient retention, 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 PHW-led intervention to those who do not. The primary outcomes will be appointment adherence, BCP adherence, and condom use. The study hypotheses are as follows: (1) PLHIV who receive the PHW intervention will have improved time to initiation of ART and retention in care (appointment adherence) compared to PLHIV not receiving the intervention; (2) PLHIV who receive the PHW 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 PHW intervention will have less risky sexual behaviors compared to PLHIV not receiving the intervention.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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|
- Time to Antiretroviral Therapy (ART) Initiation [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Time to ART Initation
- Basic Care Package Adherence [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Adherence to a basic care package of preventive care interventions (bednets, water vessels, cotrimoxazole)
- Condom Use [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Consistent, inconsistent, or never condom use.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Peer Health Worker
Peer Health Worker (PHW) assigned to participant.
Behavioral: Peer Health Worker
A trained peer health worker (person living with HIV) is assigned to support newly HIV-positive diagnosed persons.
No Intervention: Standard of Care
No Peer Health Worker assigned. Current standard of care.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366690
|Contact: Larry W W Chang, MD, MPHfirstname.lastname@example.org|
|Rakai Health Sciences Program||Recruiting|
|Principal Investigator:||Larry William Chang, MD, MPH||Johns Hopkins University|