HOLA
BehavioralTo increase condom use and HIV testing
NCT Number: NCT03276338
The intervention is based on social cognitive theory and theory of empowerment education and was developed using community-based participatory research (CBPR). This study is a result of a long-term community-university partnership that has used and will continue to use CBPR throughout all phases of research. A total of 21 Latino MSM in rural NC have been screened and recruited to serve as LHAs. The CBPR partnership selected LHAs based on qualities of natural helpers and informal leaders and having existing social networks of other Latino MSM. Eight members of each LHA's social network have been screened and recruited to participate as well. The LHAs, coupled with their social networks, have been randomized to intervention or delayed-intervention groups. LHAs (n=11) in the intervention group were trained and serve as LHAs within their social networks in Year 2. Delayed-intervention LHAs (n=10) receive the same LHA training and serve as LHAs within their social networks in Year 3. Quantitative assessment data is collected from each LHA (n=21) and the 8 members of his social network (n=189) longitudinally at: (1) baseline, (2) immediate post-intervention, and (3) 12-month follow-up. This is an "intent-to-treat" study, in which participant data are analyzed based on their randomization group.
The investigators hypothesize that participants in the HIV prevention intervention, relative to those in the delayed intervention comparison group, will demonstrate (1) increased self-reported use of condoms during sexual intercourse and (2) increased self-reported HIV testing.
The results and products from this study will be disseminated to inform public health practice, research, and policy. Results and products will include: (1) a Spanish-language intervention that is: culturally congruent and gender-specific; designed to reduce HIV risk among Latino MSM; and ready for dissemination and adaptation; (2) a deeper understanding of HIV risk and intervention among Latino MSM; and (3) insight into a CBPR process that includes community members, organizational representatives, and academic researchers.
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Notify Me18 year and older
Male
Interventional
Not applicable
The goals of this study are to refine, implement, and evaluate a culturally relevant intervention designed to reduce the disproportionate HIV burden borne by Latino men who have sex with men (MSM) in the United States (US). This application is the culmination of ongoing research from an established partnership and was developed using community-based participatory research (CBPR). The proposed research refines an intervention that was developed, implemented, and evaluated using CBPR and was found effective in increasing condom use and HIV testing among heterosexual immigrant Latino men.1 Our CBPR partnership will refine the intervention based on findings from an R21 formative CBPR study among Latino MSM in rural North Carolina (NC) as well as ongoing insights provided by members of the partnership. CBPR will continue to be used to enhance the quality and validity of this research, continuing to equitably involve community members, organizational representatives, and academic researchers in all phases of the research. Together, the partners have developed the following specific aims for this proposal:
Aim 1: Refine a culturally relevant HIV prevention intervention designed to increase condom use and HIV testing among adult Latino MSM.
Aim 2: Implement and evaluate the effectiveness of the intervention by comparing Latino MSM in the intervention to those in the delayed-intervention comparison, using a study design recommended by members of the CBPR partnership.
The Specific Aims will be met by applying principles of CBPR to:
This study will advance the field of HIV prevention research by refining, implementing, and evaluating an intervention for Latino MSM, who are disproportionately affected by HIV. Currently, there are few HIV prevention interventions with evidence of efficacy and none tailored to the unique and growing Latino immigrant communities currently settling in the southeastern US. Moreover, although LHA interventions are widely promoted, outcome data supporting LHA interventions as an approach to health promotion and disease prevention are limited. Our HoMBReS intervention, which was developed, implemented, and evaluated using CBPR, uses an LHA approach and has evidence of effectiveness.1 The investigators propose to refine it to fill important gaps in both the science and the practice of HIV prevention. The results and products from this study will be disseminated to inform public health practice, research, and policy. Results and products will include: (1) a Spanish-language intervention that is: culturally relevant and gender-specific; designed to reduce HIV risk among Latino MSM; and ready for dissemination and adaptation; (2) a deeper understanding of HIV risk and prevention among Latino MSM; and (3) insight into a research process that includes community members, organizational representatives, and academic researchers.
Study hypotheses. The investigators hypothesize that compared to participants in the delayed-intervention group, participants in the intervention group will demonstrate (a) increased self-reported use of condoms during sexual intercourse; and (b) increased self-reported HIV testing. The investigators also hypothesize that the sustainability of intervention will continue through 12-month follow-up (24 months after the Navegantes are trained).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To be eligible to participate as a social network member of a Navegante, a participant must:
Exclusion criteria
To increase condom use and HIV testing
Time frame: 4 months
Evaluate the amount of condom use at from baseline to 4 months.
Time frame: 12 months
Evaluate the change in HIV status from baseline to 12 months
Wake Forest University Health Sciences
Other
Acronym: HOLA
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