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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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:

  1. 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;
  2. 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;
  3. Recruit and enroll 12 members from the social network of each of the 20 LHAs for a total of n=240 social network members;
  4. Randomize the 20 LHAs, coupled with their social networks, into intervention and delayed-intervention comparison groups;
  5. Train and support the LHAs in 2 waves (intervention and delayed-intervention) to serve as health advisors, opinion leaders, and community advocates;
  6. 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;
  7. 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
  8. 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 groups in NCT03276338
Study groupRoleWhat they receive
InterventionExperimentalParticipation in the HOLA intervention designed to prevention HIV
Receives: Behavioral: HOLA
Delayed-interventionNo interventionDelayed 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.

  1. Change in condom use

    Evaluate the amount of condom use at from baseline to 4 months.

    Measured: 4 months

Secondary outcomes (1)
  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.

  1. First posted8 Sep 2017
  2. Study start1 Apr 2011
  3. Primary completion1 Jun 2015
  4. Study completion28 Feb 2016

Resources

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)
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

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.

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