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NCT Number: NCT01366690

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rakai Health Sciences Program

Entebee, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer Support

Behavioral

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

Primary outcomes

  1. Engagement in Care

    Time frame: 1 Year

  2. Basic Care Package Adherence

    Time frame: 1 Year

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

  3. Condom Use

    Time frame: 1 Year

    Consistent, inconsistent, or never condom use.

Secondary outcomes

  1. ART Use

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Rakai Health Sciences Program

Registry information

Official study 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

Acronym: PeerCARE

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 6, 2011
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.