HIV
Conditions
Keywords
Latino, men who have sex with men
Brief 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 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.
Interventions
BEHAVIORALSiempre Seguiré
A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care.
Sponsors
Bienestar Human Services, Inc.
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Adherence (MEMS) | 4-5 and 6-7 months post-baseline | Percentage of doses taken, of those prescribed, from electronic monitoring |
| Continuous Adherence (Self-report) | 4 and 7 months post-baseline | Percentage of doses taken, of those prescribed, self-report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dysfunctional Coping Strategies | 4 and 7 months post-baseline | 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 |
| Negative Religious Coping Strategies | 4 and 7 months post-baseline | 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 |
| Medical Mistrust (General) | 4 and 7 months post-baseline | General medical mistrust was measured with the Mistrust of Healthcare Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. |
| Functional Coping Strategies | 4 and 7 months post-baseline | 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 |
| Internalized Stigma (Sexual Orientation) | 4 and 7 months post-baseline | Internalized sexual minority stigma was assessed with the Internalized-Homophobia Scale-Revised. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. |
| Internalized Stigma (HIV) | 4 and 7 months post-baseline | Internalized HIV stigma was assessed with the Internalized AIDS-Related Stigma Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. |
| Medical Mistrust (HIV Conspiracy Beliefs) | 4 and 7 months post-baseline | HIV-specific medical mistrust was measured with the HIV Conspiracy Beliefs Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. |
| Positive Religious Coping Strategies | 4 and 7 months post-baseline | 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 |
Countries
United States
Participant flow
Pre-assignment details
Between completing the baseline survey and being randomized 5 participants were lost to follow up and 1 withdrew due to issues related to homelessness.
Participants by arm
| Arm | Count |
|---|---|
| Siempre Seguiré We will conduct a small 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.
Siempre Seguiré: A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care. | 38 |
| Control 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. | 38 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Siempre Seguiré | Total | Control |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 12.9 | 52.9 years STANDARD_DEVIATION 12.9 | 53.5 years STANDARD_DEVIATION 13.1 |
| ART Adherence MEMS | 89.2 % of doses taken, past month STANDARD_DEVIATION 17.4 | 85.9 % of doses taken, past month STANDARD_DEVIATION 20.7 | 82.3 % of doses taken, past month STANDARD_DEVIATION 23.5 |
| ART Adherence Self-report | 94.61 % of doses taken, past month STANDARD_DEVIATION 6.62 | 92.9 % of doses taken, past month STANDARD_DEVIATION 8 | 91.08 % of doses taken, past month STANDARD_DEVIATION 8.97 |
| Coping with discrimination Dysfunctional co[ping (12 Brief COPE items) | 2.09 units on a scale STANDARD_DEVIATION 0.36 | 2.12 units on a scale STANDARD_DEVIATION 0.41 | 2.14 units on a scale STANDARD_DEVIATION 0.44 |
| Coping with discrimination Functional coping (16 Brief COPE items, plus three additional items) | 2.74 units on a scale STANDARD_DEVIATION 0.45 | 2.76 units on a scale STANDARD_DEVIATION 0.49 | 2.78 units on a scale STANDARD_DEVIATION 0.48 |
| Coping with discrimination Negative religious coping (R-COPE subscale) | 0.44 units on a scale STANDARD_DEVIATION 0.48 | 0.34 units on a scale STANDARD_DEVIATION 0.42 | 0.25 units on a scale STANDARD_DEVIATION 0.35 |
| Coping with discrimination Positive religious coping (R-COPE subscale) | 1.86 units on a scale STANDARD_DEVIATION 0.66 | 2.00 units on a scale STANDARD_DEVIATION 0.65 | 2.14 units on a scale STANDARD_DEVIATION 0.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 76 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Internalized stigma (HIV) Internalized HIV stigma | 2.76 units on a scale STANDARD_DEVIATION 1.2 | 2.65 units on a scale STANDARD_DEVIATION 1.04 | 2.54 units on a scale STANDARD_DEVIATION 0.88 |
| Internalized stigma (HIV) Internalized sexual minority stigma | 1.70 units on a scale STANDARD_DEVIATION 0.96 | 1.77 units on a scale STANDARD_DEVIATION 0.9 | 1.84 units on a scale STANDARD_DEVIATION 0.84 |
| Medical mistrust General (Mistrust of Healthcare Scale) | 2.53 units on a scale STANDARD_DEVIATION 1.1 | 2.71 units on a scale STANDARD_DEVIATION 1.03 | 2.90 units on a scale STANDARD_DEVIATION 0.96 |
| Medical mistrust HIV Conspiracy Beliefs (HIV Conspiracy Beliefs Scale) | 2.33 units on a scale STANDARD_DEVIATION 1.06 | 2.32 units on a scale STANDARD_DEVIATION 0.99 | 2.30 units on a scale STANDARD_DEVIATION 0.94 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 38 Participants | 76 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
Continuous Adherence (MEMS)
Percentage of doses taken, of those prescribed, from electronic monitoring
Time frame: 4-5 and 6-7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Continuous Adherence (MEMS) | MEMS, 4-5 months post-baseline | 86.7 % of doses taken, past month | Standard Deviation 16 |
| Siempre Seguiré | Continuous Adherence (MEMS) | MEMS, 6-7 months post baseline | 85.5 % of doses taken, past month | Standard Deviation 19.8 |
| Control | Continuous Adherence (MEMS) | MEMS, 4-5 months post-baseline | 79.0 % of doses taken, past month | Standard Deviation 23 |
| Control | Continuous Adherence (MEMS) | MEMS, 6-7 months post baseline | 79.7 % of doses taken, past month | Standard Deviation 19.9 |
p-value: 0.0695% CI: [-0.55, 19.03]Regression, Linear
Primary
Continuous Adherence (Self-report)
Percentage of doses taken, of those prescribed, self-report
Time frame: 4 and 7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Continuous Adherence (Self-report) | 4-month follow-up | 97.48 % of doses taken, past month | Standard Deviation 5.42 |
| Siempre Seguiré | Continuous Adherence (Self-report) | 7-month follow-up | 99.17 % of doses taken, past month | Standard Deviation 1.51 |
| Control | Continuous Adherence (Self-report) | 4-month follow-up | 94.57 % of doses taken, past month | Standard Deviation 6.56 |
| Control | Continuous Adherence (Self-report) | 7-month follow-up | 92.91 % of doses taken, past month | Standard Deviation 16.78 |
p-value: 0.0295% CI: [0.7, 8.3]Regression, Linear
Secondary
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
Time frame: 4 and 7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Dysfunctional Coping Strategies | 4-month follow-up | 2.05 units on a scale | Standard Deviation 0.33 |
| Siempre Seguiré | Dysfunctional Coping Strategies | 7-month follow-up | 2.06 units on a scale | Standard Deviation 0.38 |
| Control | Dysfunctional Coping Strategies | 4-month follow-up | 2.09 units on a scale | Standard Deviation 0.41 |
| Control | Dysfunctional Coping Strategies | 7-month follow-up | 2.09 units on a scale | Standard Deviation 0.54 |
Comparison: Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.p-value: 0.8195% CI: [-0.18, 0.14]Regression, Linear
Secondary
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
Time frame: 4 and 7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Functional Coping Strategies | 4-month follow-up | 2.75 units on a scale | Standard Deviation 0.43 |
| Siempre Seguiré | Functional Coping Strategies | 7-month follow-up | 2.82 units on a scale | Standard Deviation 0.44 |
| Control | Functional Coping Strategies | 4-month follow-up | 2.68 units on a scale | Standard Deviation 0.36 |
| Control | Functional Coping Strategies | 7-month follow-up | 2.74 units on a scale | Standard Deviation 0.45 |
p-value: 0.3995% CI: [-0.1, 0.26]Regression, Linear
Secondary
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.
Time frame: 4 and 7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Internalized Stigma (HIV) | 4 months post-baseline | 2.38 units on a scale | Standard Deviation 0.93 |
| Siempre Seguiré | Internalized Stigma (HIV) | 7 months post-baseline | 2.14 units on a scale | Standard Deviation 0.9 |
| Control | Internalized Stigma (HIV) | 4 months post-baseline | 2.38 units on a scale | Standard Deviation 0.98 |
| Control | Internalized Stigma (HIV) | 7 months post-baseline | 2.65 units on a scale | Standard Deviation 1.17 |
Comparison: Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.p-value: 0.195% CI: [-0.73, 0.06]Regression, Linear
Secondary
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.
Time frame: 4 and 7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Internalized Stigma (Sexual Orientation) | 4 months post-baseline | 1.53 units on a scale | Standard Deviation 0.79 |
| Siempre Seguiré | Internalized Stigma (Sexual Orientation) | 7 months post-baseline | 1.68 units on a scale | Standard Deviation 1.06 |
| Control | Internalized Stigma (Sexual Orientation) | 4 months post-baseline | 1.59 units on a scale | Standard Deviation 0.69 |
| Control | Internalized Stigma (Sexual Orientation) | 7 months post-baseline | 1.59 units on a scale | Standard Deviation 0.85 |
Comparison: Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.p-value: 0.7195% CI: [-0.32, 0.47]Regression, Linear
Secondary
Medical Mistrust (General)
General medical mistrust was measured with the Mistrust of Healthcare Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Time frame: 4 and 7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Medical Mistrust (General) | 4 months post-baseline | 2.34 units on a scale | Standard Deviation 0.94 |
| Siempre Seguiré | Medical Mistrust (General) | 7 months post-baseline | 2.28 units on a scale | Standard Deviation 1.2 |
| Control | Medical Mistrust (General) | 4 months post-baseline | 2.78 units on a scale | Standard Deviation 0.96 |
| Control | Medical Mistrust (General) | 7 months post-baseline | 2.88 units on a scale | Standard Deviation 1.08 |
Comparison: Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.p-value: 0.1695% CI: [-0.78, 0.13]Regression, Linear
Secondary
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.
Time frame: 4 and 7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Medical Mistrust (HIV Conspiracy Beliefs) | 4 months post-baseline | 1.81 units on a scale | Standard Deviation 0.86 |
| Siempre Seguiré | Medical Mistrust (HIV Conspiracy Beliefs) | 7 months post-baseline | 1.90 units on a scale | Standard Deviation 1.03 |
| Control | Medical Mistrust (HIV Conspiracy Beliefs) | 4 months post-baseline | 2.26 units on a scale | Standard Deviation 0.9 |
| Control | Medical Mistrust (HIV Conspiracy Beliefs) | 7 months post-baseline | 2.40 units on a scale | Standard Deviation 0.9 |
Comparison: Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.p-value: 0.0295% CI: [-0.84, -0.09]Regression, Linear
Secondary
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
Time frame: 4 and 7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Negative Religious Coping Strategies | 4 months post-baseline | 0.17 units on a scale | Standard Deviation 0.24 |
| Siempre Seguiré | Negative Religious Coping Strategies | 7 months post-baseline | 0.22 units on a scale | Standard Deviation 0.4 |
| Control | Negative Religious Coping Strategies | 4 months post-baseline | 0.34 units on a scale | Standard Deviation 0.52 |
| Control | Negative Religious Coping Strategies | 7 months post-baseline | 0.30 units on a scale | Standard Deviation 0.48 |
Comparison: Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.p-value: 0.0695% CI: [-0.37, 0.01]Regression, Linear
Secondary
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
Time frame: 4 and 7 months post-baseline
Population: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Siempre Seguiré | Positive Religious Coping Strategies | 4 months post-baseline | 1.84 units on a scale | Standard Deviation 0.85 |
| Siempre Seguiré | Positive Religious Coping Strategies | 7 months post-baseline | 1.72 units on a scale | Standard Deviation 0.84 |
| Control | Positive Religious Coping Strategies | 4 months post-baseline | 2.08 units on a scale | Standard Deviation 0.65 |
| Control | Positive Religious Coping Strategies | 7 months post-baseline | 2.08 units on a scale | Standard Deviation 0.65 |
Comparison: Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.p-value: 0.5495% CI: [-0.37, 0.2]Regression, Linear