HIV/AIDSHOLANCT03276338
Using CBPR to Reduce HIV Risk Among Immigrant Latino MSM
A study testing HOLA in people with HIV/AIDS, run by Wake Forest University Health Sciences.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- HOLA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2011to 28 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identify as Latino or Hispanic;
- be 18 years of age;
- report MSM behavior since age 18;
- have some Spanish-language literacy;
- and provide informed consent.
- To be eligible to participate as a social network member of a Navegante, a participant must:
Show all 10Show fewer
- self-identify as Latino or Hispanic;
- be 18 years of age;
- report MSM behavior since age 18;
- and provide informed consent.
Who cannot join
- having participated in the HoMBReS or HoMBReS-2 interventions, or in the refinement of the HOLA intervention.
About this study
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.
Read the detailed description
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:
- Refine the HoMBReS intervention, which has been found effective in increasing condom use and HIV testing among heterosexual Latino men, while retaining the integrity of intervention themes, concepts, and approaches;
- Recruit and enroll adult male Latino lay health advisors (LHAs; total n=20) who represent 20 distinct social networks of Latino MSM within central NC;
- Recruit and enroll 12 members from the social network of each of the 20 LHAs for a total of n=240 social network members;
- Randomize the 20 LHAs, coupled with their social networks, into intervention and delayed-intervention comparison groups;
- Train and support the LHAs in 2 waves (intervention and delayed-intervention) to serve as health advisors, opinion leaders, and community advocates;
- Evaluate the impact of the intervention by comparing rates of change in condom use and HIV testing from baseline to immediate post-intervention between those in the intervention group (10 LHAs; 120 social network members) and their peers in the delayed-intervention group (10 LHAs; 120 social network members), who will not have been exposed to the intervention, using an interviewer-administered assessment;
- Evaluate the sustainability of intervention by comparing rates of change in condom use and HIV testing from immediate post-intervention to a 12-month follow-up using data from both the intervention and delayed-intervention groups who will all have been exposed to the intervention; and
- Interpret and disseminate findings to community members, other key stakeholders, and policy leaders at the local, regional, and national levels.
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).
- Conditions
- HIV/AIDS
- Being tested
- HOLA
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOLABehavioural
To increase condom use and HIV testing
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participation in the HOLA intervention designed to prevention HIV Receives: Behavioral: HOLA |
| Delayed-intervention | No intervention | Delayed intervention with participation in HOLA intervention after follow-up data have been collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in condom use
Evaluate the amount of condom use at from baseline to 4 months.
Measured: 4 months
Secondary outcomes (1)
Change in HIV status
Evaluate the change in HIV status from baseline to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Apr 2011
- Primary completion1 Jun 2015
- Study completion28 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Scott Rhodes, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276338
- Sponsor's protocol ID
- IRB00012292
- Other IDs
- 5R01MH087339-04
- Acronym
- HOLA
- Status last verified
- Aug 2018
- First submitted
- 26 May 2017
- Last updated
- 10 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using CBPR to Reduce HIV Risk Among Immigrant Latino MSM
- ClinicalTrials.gov ID
- NCT03276338
- Acronym / sponsor ID
- HOLA / IRB00012292
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 28 Feb 2016 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Refine the HoMBReS intervention, which has been found effective in increasing condom use and HIV testing among heterosexual Latino men, while retaining the integrity of intervention themes, concepts, and approaches;
- Recruit and enroll adult male Latino lay health advisors (LHAs; total n=20) who represent 20 distinct social networks of Latino MSM within central NC;
- Recruit and enroll 12 members from the social network of each of the 20 LHAs for a total of n=240 social network members;
- Randomize the 20 LHAs, coupled with their social networks, into intervention and delayed-intervention comparison groups;
- Train and support the LHAs in 2 waves (intervention and delayed-intervention) to serve as health advisors, opinion leaders, and community advocates;
- Evaluate the impact of the intervention by comparing rates of change in condom use and HIV testing from baseline to immediate post-intervention between those in the intervention group (10 LHAs; 120 social network members) and their peers in the delayed-intervention group (10 LHAs; 120 social network members), who will not have been exposed to the intervention, using an interviewer-administered assessment;
- Evaluate the sustainability of intervention by comparing rates of change in condom use and HIV testing from immediate post-intervention to a 12-month follow-up using data from both the intervention and delayed-intervention groups who will all have been exposed to the intervention; and
- Interpret and disseminate findings to community members, other key stakeholders, and policy leaders at the local, regional, and national levels.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: HOLAParticipation in the HOLA intervention designed to prevention HIV |
| Delayed-intervention | No intervention | –Delayed intervention with participation in HOLA intervention after follow-up data have been collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- self-identify as Latino or Hispanic;
- be 18 years of age;
- report MSM behavior since age 18;
- have some Spanish-language literacy;
- and provide informed consent.
Key exclusion criteria (1 listed)
- having participated in the HoMBReS or HoMBReS-2 interventions, or in the refinement of the HOLA intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOLATo increase condom use and HIV testing | Behavioural | Intervention |
Primary outcome
Change in condom use
Time frame: 4 months
Evaluate the amount of condom use at from baseline to 4 months.
1 secondary outcome
Change in HIV status
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Rhodes principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing HOLA in people with HIV/AIDS, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in condom use (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.