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

This study is currently recruiting participants.
Verified March 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Larry William Chang, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01366690
First received: June 2, 2011
Last updated: March 28, 2012
Last verified: March 2012

June 2, 2011
March 28, 2012
June 2011
August 2013   (final data collection date for primary outcome measure)
  • 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.
  • Time to 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.
Complete list of historical versions of study NCT01366690 on ClinicalTrials.gov Archive Site
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The PeerCARE Study (Peer Community-based Assistant in REtention)
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 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.[2] 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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HIV
Behavioral: Peer Health Worker
A trained peer health worker (person living with HIV) is assigned to support newly HIV-positive diagnosed persons.
  • Experimental: Peer Health Worker
    Peer Health Worker (PHW) assigned to participant.
    Intervention: Behavioral: Peer Health Worker
  • No Intervention: Standard of Care
    No Peer Health Worker assigned. Current standard of care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
June 2014
August 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Larry W W Chang, MD, MPH 4105228069 larrywillchang@gmail.com
Uganda
 
NCT01366690
NA_00040431
No
Larry William Chang, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Larry William Chang, MD, MPH Johns Hopkins University
Johns Hopkins University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP