HIV Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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