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

This study has been completed.
Sponsor:
Collaborator:
Rakai Health Sciences Program
Information provided by (Responsible Party):
Larry William Chang, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01366690
First received: June 2, 2011
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 Intervention
HIV
Behavioral: Peer Support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Engagement in Care [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • 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.


Secondary Outcome Measures:
  • ART Use [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2011
Study Completion Date: June 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366690

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

No publications provided

Responsible Party: Larry William Chang, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01366690     History of Changes
Other Study ID Numbers: NA_00040431
Study First Received: June 2, 2011
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
HIV
community health workers
randomized trial
task shifting
Uganda
retention
operations research
implementation research

ClinicalTrials.gov processed this record on November 24, 2014