Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM (PODER)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 19, 2011 | ||||||||
| Last Updated Date | January 4, 2013 | ||||||||
| Start Date ICMJE | December 2012 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Retention in care [ Time Frame: Six month follow up ] [ Designated as safety issue: No ] Retention in care will be assessed through the following measures: HIV medical care visits, ART use, self-reported adherence, acute care utilization, viral load, and health-related quality of life |
||||||||
| Original Primary Outcome Measures ICMJE |
|
||||||||
| Change History | Complete list of historical versions of study NCT01457066 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Intermediate outcome variables [ Time Frame: Six month follow up ] [ Designated as safety issue: No ] Social support, perceived social norms, retention knowledge, retention self-efficacy, outcome expectations |
||||||||
| 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 | Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM | ||||||||
| Official Title ICMJE | Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM | ||||||||
| Brief Summary | The goal of this proposal is to culturally adapt and tailor an existing, theory-based intervention, using state-of-the-art methods designed to maximize cultural sensitivity, feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized controlled trial (n=60 intervention; n=60 control). |
||||||||
| Detailed Description | While early receipt of and adherence to antiretroviral therapy are critical for effective HIV treatment, engagement with and retention in HIV care are essential first steps. Retention in HIV care is particularly important for traditionally disadvantaged groups, such as Latino MSMs, who are over-represented in the HIV epidemic. HIV+ Latino MSM therefore urgently need interventions to improve their retention in HIV care, which may be affected by a number of culture-specific factors. The goal of this proposal is to culturally adapt and tailor an existing, theory-based intervention, using state-of-the-art methods designed to maximize cultural sensitivity, feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized controlled trial (n=60 intervention; n=60 control). The study will be conducted among insufficiently retained HIV+ Latino MSM at AltaMed, the largest provider of HIV medical services for Latinos in Los Angeles. The proposed intervention is designed to retain participants in HIV care by addressing barriers to and facilitators of HIV care salient to Latinos, using group-based as well as one-on-one, peer-based learning approaches. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
||||||||
| Condition ICMJE | HIV | ||||||||
| Intervention ICMJE | Behavioral: Peer Navigator Intervention
Peer navigators will teach HIV retention and linkage skills and knowledge using group-based as well as one-on-one, peer-based learning approaches. |
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 70 | ||||||||
| Estimated Completion Date | October 2013 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria include: 1) being HIV+; 2) > 18 years old; 3) male; 4) fluent in Spanish; 5) self-identify as having Latino or Hispanic ethnicity; 6) Self-identify as gay or as ever having sex with men; 7) Must have scheduled visit with AltaMed in the prior 12 months and have a) fewer than one visit in the prior four months or b) detectable viral load Exclusion Criteria include 1) not having a scheduled visit with AltaMed in the prior 12 months and having a) more than one visit in the prior four months or b) undetectable viral load; 2) being unable to give informed consent; 3) Lack of Spanish language skills |
||||||||
| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01457066 | ||||||||
| Other Study ID Numbers ICMJE | R34MH089719-01A1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | William Cunningham, University of California, Los Angeles | ||||||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of California, Los Angeles | ||||||||
| Verification Date | January 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||