HIVNCT03432819
A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM
A study testing Siempre Seguiré in people with HIV, run by RAND at 1 site in United States.
Trial summary
R34-funded study to pilot test an intervention to improve coping with discrimination and adherence among Latino men who have sex with men (MSM) living with HIV. The proposed research aims to modify and refine Siempre Seguiré, a culturally congruent cognitive behavior therapy group intervention for HIV-positive Latino… 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
- What is being tested?
- Siempre Seguiré
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2018to 16 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years-old or older, HIV-positive, biologically male at birth and continue to identify as male, identify as Latino, report having sex with men in the past 12 months, and prescribed ART.
Who cannot join
- Being unwilling or unable to provide informed consent; having mental health problems that require immediate treatment (e.g., psychotic symptoms) or a diagnosed mental disorder that would limit ability to participate (e.g., dementia); and cognitive impairments that result in limited ability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bienestar Human Services, Inc.
Los Angeles, California, 90022
About this study
R34-funded study to pilot test an intervention to improve coping with discrimination and adherence among Latino men who have sex with men (MSM) living with HIV. The proposed research aims to modify and refine Siempre Seguiré, a culturally congruent cognitive behavior therapy group intervention for HIV-positive Latino men who have sex with men (LMSM), to include strategies for ART adherence and retention in HIV care; and to conduct a small randomized pilot of Siempre Seguiré to examine feasibility and acceptability, as well as to explore preliminary effects on coping responses to discrimination and antiretroviral treatment adherence among LMSM living with HIV.
Read the detailed description
HIV-related disparities in diagnosis and disease outcomes persist among Latinos, and Latinos living with HIV show a lower percentage of viral suppression compared to the general HIV-positive population. A growing body of work suggests that stigma and discrimination contribute to health disparities, especially among people living with HIV, who may experience discrimination due to multiple stigmatized identities related to HIV-serostatus, race/ethnicity, and sexual orientation. Internalized stigma and discrimination may lead to health-related disparities by increasing detrimental physiological stress responses, resulting in maladaptive coping and poor health behaviors, including non-adherence to treatment. Moreover, the chronic stress of discrimination may weaken immune function, leading to worse HIV outcomes, including increased HIV viral load. The proposed research will integrate adherence skills-building strategies into a recently developed intervention, Siempre Seguiré, an 8-session group cognitive behavioral therapy (CBT) intervention for HIV-positive Latino men who have sex with men (LMSM) that aims to improve adaptive coping responses to discrimination. The specific aims are: (1) To modify and refine Siempre Seguiré, a newly developed culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for antiretroviral treatment adherence and retention in HIV care; and (2) To conduct a small randomized pilot of Siempre Seguiré to examine feasibility and acceptability, as well as to explore preliminary effects on: (a) coping responses to discrimination; and (b) antiretroviral treatment adherence, viral load suppression, and HIV care retention, among LMSM living with HIV. In Phase 1, HIV treatment adherence intervention experts and key stakeholders, including a community advisory board, will help to refine our pilot intervention as needed and update our manual to integrate information and skills building regarding HIV treatment adherence and retention in care. In Phase 2, a small randomized controlled trial of 80 participants (40 intervention participants divided evenly over 4 intervention groups vs. 40 wait-list control participants) will be conducted. Participants will complete surveys at baseline, and 4- and 6-months post-baseline to assess coping and HIV care processes and outcomes. Adherence will be electronically monitored, and viral load will be collected from medical providers at baseline and at 6-month follow-up. Intervention group sessions will take place once per week for 8 weeks. Sessions will take place in a private room at Bienestar (a Latino-serving AIDS service organization in LAC) and will last approximately 90 minutes. We hypothesize that the intervention will improve coping responses to discrimination and HIV treatment adherence.
- Conditions
- HIV
- Being tested
- Siempre Seguiré
- Keywords
- Latino, men who have sex with men
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siempre SeguiréBehavioural
A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care.
| Study group | Role | What they receive |
|---|---|---|
| Siempre Seguiré | Experimental | We will conduct a small randomized controlled trial (RCT), testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT. Receives: Behavioral: Siempre Seguiré |
| Control | No intervention | Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Adherence (MEMS)
Percentage of doses taken, of those prescribed, from electronic monitoring
Measured: 4-5 and 6-7 months post-baseline
Continuous Adherence (Self-report)
Percentage of doses taken, of those prescribed, self-report
Measured: 4 and 7 months post-baseline
Secondary outcomes (8)
Functional Coping Strategies
Functional coping strategies as measured by 16 Brief COPE items on active coping, acceptance, social support, positive reframing, planning, humor, and religion, and three additional functional coping items based on prior qualitative research on coping in communities of color ("I tell myself that other people are ignorant"; "I avoid certain situations or people so that I am not discriminated against in the future"; and "I change the way that I dress or talk so that I am not discriminated against in the future"). Responses were 1 = I haven't been doing this at all, 2 = I've been doing this a little bit, 3 = I've been doing this a medium amount, and 4 = I've been doing this a lot in response to discrimination
Measured: 4 and 7 months post-baseline
Positive Religious Coping Strategies
Positive religious coping strategies as measured by an R-COPE sub-scale to assess secure relationships with a divine force/spiritual connectedness. Responses were 1 = I haven't been doing this at all, 2 = I've been doing this a little bit, 3 = I've been doing this a medium amount, and 4 = I've been doing this a lot in response to discrimination
Measured: 4 and 7 months post-baseline
Dysfunctional Coping Strategies
Dysfunctional/ineffective coping strategies dysfunctional/ineffective as measured by 12 Brief COPE items on denial, substance use, behavioral disengagement, venting, self-blame, and self-distraction. Responses were 1 = I haven't been doing this at all, 2 = I've been doing this a little bit, 3 = I've been doing this a medium amount, and 4 = I've been doing this a lot in response to discrimination
Measured: 4 and 7 months post-baseline
Negative Religious Coping Strategies
Negative religious coping strategies as measured by an R-COPE sub-scale to assess underlying spiritual tensions/internal struggles. Responses were 1 = I haven't been doing this at all, 2 = I've been doing this a little bit, 3 = I've been doing this a medium amount, and 4 = I've been doing this a lot in response to discrimination
Measured: 4 and 7 months post-baseline
Medical Mistrust (General)
General medical mistrust was measured with the Mistrust of Healthcare Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Measured: 4 and 7 months post-baseline
Medical Mistrust (HIV Conspiracy Beliefs)
HIV-specific medical mistrust was measured with the HIV Conspiracy Beliefs Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Measured: 4 and 7 months post-baseline
Internalized Stigma (Sexual Orientation)
Internalized sexual minority stigma was assessed with the Internalized-Homophobia Scale-Revised. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Measured: 4 and 7 months post-baseline
Internalized Stigma (HIV)
Internalized HIV stigma was assessed with the Internalized AIDS-Related Stigma Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Measured: 4 and 7 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start27 Mar 2018
- Primary completion12 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Bienestar Human Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Laura Bogart, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432819
- Sponsor's protocol ID
- R34MH113413
- Status last verified
- Mar 2023
- First submitted
- 31 Jan 2018
- Last updated
- 29 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barreras JL, Bogart LM, MacCarthy S, Klein DJ, Pantalone DW. Discrimination and adherence in a cross-sectional study of Latino sexual minority men with HIV: Coping with discrimination as a mediator and coping self-efficacy as a moderator. J Behav Med. 2023 Dec;46(6):1057-1067. doi: 10.1007/s10865-023-00426-6. Epub 2023 Jul 1.
PubMed 37392342Bogart LM, Barreras JL, Gonzalez A, Klein DJ, Marsh T, Agniel D, Pantalone DW. Pilot Randomized Controlled Trial of an Intervention to Improve Coping with Intersectional Stigma and Medication Adherence Among HIV-Positive Latinx Sexual Minority Men. AIDS Behav. 2021 Jun;25(6):1647-1660. doi: 10.1007/s10461-020-03081-z. Epub 2020 Nov 24.
PubMed 33231847
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM
- ClinicalTrials.gov ID
- NCT03432819
- Acronym / sponsor ID
- R34MH113413
- Conditions
- HIV
- Keywords
- Latino, men who have sex with men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Bienestar Human Services, Inc.
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
R34-funded study to pilot test an intervention to improve coping with discrimination and adherence among Latino men who have sex with men (MSM) living with HIV. The proposed research aims to modify and refine Siempre Seguiré, a culturally congruent cognitive behavior therapy group intervention for HIV-positive Latino men who have sex with men (LMSM), to include strategies for ART adherence and retention in HIV care; and to conduct a small randomized pilot of Siempre Seguiré to examine feasibility and acceptability, as well as to explore preliminary effects on coping responses to discrimination and antiretroviral treatment adherence among LMSM living with HIV.
Detailed description
HIV-related disparities in diagnosis and disease outcomes persist among Latinos, and Latinos living with HIV show a lower percentage of viral suppression compared to the general HIV-positive population. A growing body of work suggests that stigma and discrimination contribute to health disparities, especially among people living with HIV, who may experience discrimination due to multiple stigmatized identities related to HIV-serostatus, race/ethnicity, and sexual orientation. Internalized stigma and discrimination may lead to health-related disparities by increasing detrimental physiological stress responses, resulting in maladaptive coping and poor health behaviors, including non-adherence to treatment. Moreover, the chronic stress of discrimination may weaken immune function, leading to worse HIV outcomes, including increased HIV viral load. The proposed research will integrate adherence skills-building strategies into a recently developed intervention, Siempre Seguiré, an 8-session group cognitive behavioral therapy (CBT) intervention for HIV-positive Latino men who have sex with men (LMSM) that aims to improve adaptive coping responses to discrimination. The specific aims are: (1) To modify and refine Siempre Seguiré, a newly developed culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for antiretroviral treatment adherence and retention in HIV care; and (2) To conduct a small randomized pilot of Siempre Seguiré to examine feasibility and acceptability, as well as to explore preliminary effects on: (a) coping responses to discrimination; and (b) antiretroviral treatment adherence, viral load suppression, and HIV care retention, among LMSM living with HIV. In Phase 1, HIV treatment adherence intervention experts and key stakeholders, including a community advisory board, will help to refine our pilot intervention as needed and update our manual to integrate information and skills building regarding HIV treatment adherence and retention in care. In Phase 2, a small randomized controlled trial of 80 participants (40 intervention participants divided evenly over 4 intervention groups vs. 40 wait-list control participants) will be conducted. Participants will complete surveys at baseline, and 4- and 6-months post-baseline to assess coping and HIV care processes and outcomes. Adherence will be electronically monitored, and viral load will be collected from medical providers at baseline and at 6-month follow-up. Intervention group sessions will take place once per week for 8 weeks. Sessions will take place in a private room at Bienestar (a Latino-serving AIDS service organization in LAC) and will last approximately 90 minutes. We hypothesize that the intervention will improve coping responses to discrimination and HIV treatment adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Siempre Seguiré | Experimental | Behavioral: Siempre SeguiréWe will conduct a small randomized controlled trial (RCT), testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT. |
| Control | No intervention | –Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years-old or older, HIV-positive, biologically male at birth and continue to identify as male, identify as Latino, report having sex with men in the past 12 months, and prescribed ART.
Key exclusion criteria (1 listed)
- Being unwilling or unable to provide informed consent; having mental health problems that require immediate treatment (e.g., psychotic symptoms) or a diagnosed mental disorder that would limit ability to participate (e.g., dementia); and cognitive impairments that result in limited ability to provide informed consent.
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 |
|---|---|---|
| Siempre SeguiréA culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care. | Behavioural | Siempre Seguiré |
Primary outcome
Continuous Adherence (MEMS)
Time frame: 4-5 and 6-7 months post-baseline
Percentage of doses taken, of those prescribed, from electronic monitoring
Continuous Adherence (Self-report)
Time frame: 4 and 7 months post-baseline
Percentage of doses taken, of those prescribed, self-report
8 secondary outcomes
Functional Coping Strategies
Time frame: 4 and 7 months post-baseline
Positive Religious Coping Strategies
Time frame: 4 and 7 months post-baseline
Dysfunctional Coping Strategies
Time frame: 4 and 7 months post-baseline
Negative Religious Coping Strategies
Time frame: 4 and 7 months post-baseline
Medical Mistrust (General)
Time frame: 4 and 7 months post-baseline
Medical Mistrust (HIV Conspiracy Beliefs)
Time frame: 4 and 7 months post-baseline
Internalized Stigma (Sexual Orientation)
Time frame: 4 and 7 months post-baseline
Internalized Stigma (HIV)
Time frame: 4 and 7 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37392342Barreras JL, Bogart LM, MacCarthy S, Klein DJ, Pantalone DW. Discrimination and adherence in a cross-sectional study of Latino sexual minority men with HIV: Coping with discrimination as a mediator and coping self-efficacy as a moderator. J Behav Med. 2023 Dec;46(6):1057-1067. doi: 10.1007/s10865-023-00426-6. Epub 2023 Jul 1.
- Derived from this study: PubMed 33231847Bogart LM, Barreras JL, Gonzalez A, Klein DJ, Marsh T, Agniel D, Pantalone DW. Pilot Randomized Controlled Trial of an Intervention to Improve Coping with Intersectional Stigma and Medication Adherence Among HIV-Positive Latinx Sexual Minority Men. AIDS Behav. 2021 Jun;25(6):1647-1660. doi: 10.1007/s10461-020-03081-z. Epub 2020 Nov 24.
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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.
Laura Bogart, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Siempre Seguiré in people with HIV, run by RAND at 1 site in United States.
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 1 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Continuous Adherence (MEMS) (time frame: 4-5 and 6-7 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03432819, which also lists 2 linked publications.
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 29 Mar 2023.