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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01366690
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : September 9, 2014
Rakai Health Sciences Program
Information provided by (Responsible Party):
Larry William Chang, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Peer Support Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Peer Support
Peer supporter assigned to participant.
Behavioral: Peer Support
A trained peer supporter is assigned to support newly HIV-positive diagnosed persons.

No Intervention: Standard of Care
No peer assigned. Current standard of care.

Primary Outcome Measures :
  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 Outcome Measures :
  1. ART Use [ Time Frame: 1 Year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01366690

Rakai Health Sciences Program
Entebee, Uganda
Sponsors and Collaborators
Johns Hopkins University
Rakai Health Sciences Program
Principal Investigator: Larry William Chang, MD, MPH Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Larry William Chang, Assistant Professor of Medicine, Johns Hopkins University Identifier: NCT01366690     History of Changes
Other Study ID Numbers: NA_00040431
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Larry William Chang, Johns Hopkins University:
community health workers
randomized trial
task shifting
operations research
implementation research