Clinical trial NCT01366690: The PeerCARE Study (Peer Community-based Assistant in REtention)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
community health workers
randomized trial
task shifting
Uganda
retention
operations research
implementation research
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Rakai Health Sciences Program
First posted: 2011-06-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Engagement in Care
timeFrame: 1 Year
measure: Basic Care Package Adherence
timeFrame: 1 Year
measure: Condom Use
timeFrame: 1 Year
Secondary outcomes:
measure: ART Use
timeFrame: 1 Year
Other outcomes:
Locations:
city: Entebee
country: Uganda
facility: Rakai Health Sciences Program
Study officials:
affiliation: Johns Hopkins University
name: Larry William Chang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.