The PeerCARE Study (Peer Community-based Assistant in REtention)
| Tracking Information | |||||
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| First Received Date ICMJE | June 2, 2011 | ||||
| Last Updated Date | March 28, 2012 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT01366690 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The PeerCARE Study (Peer Community-based Assistant in REtention) | ||||
| Official Title ICMJE | 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 | ||||
| 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 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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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | HIV | ||||
| Intervention ICMJE | Behavioral: Peer Health Worker
A trained peer health worker (person living with HIV) is assigned to support newly HIV-positive diagnosed persons. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 250 | ||||
| Estimated Completion Date | June 2014 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: See above. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Uganda | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01366690 | ||||
| Other Study ID Numbers ICMJE | NA_00040431 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Larry William Chang, Johns Hopkins University | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Johns Hopkins University | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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