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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366690
First Posted: June 6, 2011
Last Update Posted: September 9, 2014
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.
Collaborator:
Rakai Health Sciences Program
Information provided by (Responsible Party):
Larry William Chang, Johns Hopkins University
June 2, 2011
June 6, 2011
September 9, 2014
June 2011
August 2013   (Final data collection date for primary outcome measure)
  • Engagement in Care [ Time Frame: 1 Year ]
  • Basic Care Package Adherence [ Time Frame: 1 Year ]
    Adherence to a basic care package of preventive care interventions (bednets, water vessels, cotrimoxazole)
  • Condom Use [ Time Frame: 1 Year ]
    Consistent, inconsistent, or never condom use.
  • Time to ART Initiation [ Time Frame: 1 Year ]
    Time to ART Initation
  • Basic Care Package Adherence [ Time Frame: 1 Year ]
    Adherence to a basic care package of preventive care interventions (bednets, water vessels, cotrimoxazole)
  • Condom Use [ Time Frame: 1 Year ]
    Consistent, inconsistent, or never condom use.
Complete list of historical versions of study NCT01366690 on ClinicalTrials.gov Archive Site
ART Use [ Time Frame: 1 Year ]
Not Provided
Not Provided
Not Provided
 
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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
HIV
Behavioral: Peer Support
A trained peer supporter is assigned to support newly HIV-positive diagnosed persons.
  • Experimental: Peer Support
    Peer supporter assigned to participant.
    Intervention: Behavioral: Peer Support
  • No Intervention: Standard of Care
    No peer assigned. Current standard of care.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
 
NCT01366690
NA_00040431
No
Not Provided
Not Provided
Larry William Chang, Johns Hopkins University
Johns Hopkins University
Rakai Health Sciences Program
Principal Investigator: Larry William Chang, MD, MPH Johns Hopkins University
Johns Hopkins University
September 2014

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