Trial Outcomes & Findings for A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM (NCT NCT03432819)
NCT ID: NCT03432819
Last Updated: 2023-03-29
Results Overview
Percentage of doses taken, of those prescribed, from electronic monitoring
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
4-5 and 6-7 months post-baseline
Results posted on
2023-03-29
Participant Flow
Between completing the baseline survey and being randomized 5 participants were lost to follow up and 1 withdrew due to issues related to homelessness.
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
Baseline Characteristics
The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
Baseline characteristics by cohort
| Measure |
Siempre Seguiré
n=38 Participants
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.
|
Control
n=38 Participants
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.
|
Total
n=76 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
52.4 years
STANDARD_DEVIATION 12.9 • n=38 Participants
|
53.5 years
STANDARD_DEVIATION 13.1 • n=38 Participants
|
52.9 years
STANDARD_DEVIATION 12.9 • n=76 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=38 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=38 Participants
|
38 Participants
n=38 Participants
|
76 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=38 Participants
|
38 Participants
n=38 Participants
|
76 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=38 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=38 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=76 Participants
|
|
ART Adherence
Self-report
|
94.61 % of doses taken, past month
STANDARD_DEVIATION 6.62 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
91.08 % of doses taken, past month
STANDARD_DEVIATION 8.97 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
92.9 % of doses taken, past month
STANDARD_DEVIATION 8.0 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
|
ART Adherence
MEMS
|
89.2 % of doses taken, past month
STANDARD_DEVIATION 17.4 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
82.3 % of doses taken, past month
STANDARD_DEVIATION 23.5 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
85.9 % of doses taken, past month
STANDARD_DEVIATION 20.7 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
|
Coping with discrimination
Functional coping (16 Brief COPE items, plus three additional items)
|
2.74 units on a scale
STANDARD_DEVIATION 0.45 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.78 units on a scale
STANDARD_DEVIATION 0.48 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.76 units on a scale
STANDARD_DEVIATION 0.49 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
|
Coping with discrimination
Dysfunctional co[ping (12 Brief COPE items)
|
2.09 units on a scale
STANDARD_DEVIATION 0.36 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.14 units on a scale
STANDARD_DEVIATION 0.44 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.12 units on a scale
STANDARD_DEVIATION 0.41 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
|
Internalized stigma (HIV)
Internalized sexual minority stigma
|
1.70 units on a scale
STANDARD_DEVIATION 0.96 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
1.84 units on a scale
STANDARD_DEVIATION 0.84 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
1.77 units on a scale
STANDARD_DEVIATION 0.90 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
|
Coping with discrimination
Positive religious coping (R-COPE subscale)
|
1.86 units on a scale
STANDARD_DEVIATION 0.66 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.14 units on a scale
STANDARD_DEVIATION 0.62 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.00 units on a scale
STANDARD_DEVIATION 0.65 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
|
Coping with discrimination
Negative religious coping (R-COPE subscale)
|
0.44 units on a scale
STANDARD_DEVIATION 0.48 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
0.25 units on a scale
STANDARD_DEVIATION 0.35 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
0.34 units on a scale
STANDARD_DEVIATION 0.42 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
|
Medical mistrust
General (Mistrust of Healthcare Scale)
|
2.53 units on a scale
STANDARD_DEVIATION 1.10 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.90 units on a scale
STANDARD_DEVIATION 0.96 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.71 units on a scale
STANDARD_DEVIATION 1.03 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
|
Medical mistrust
HIV Conspiracy Beliefs (HIV Conspiracy Beliefs Scale)
|
2.33 units on a scale
STANDARD_DEVIATION 1.06 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.30 units on a scale
STANDARD_DEVIATION 0.94 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.32 units on a scale
STANDARD_DEVIATION 0.99 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
|
Internalized stigma (HIV)
Internalized HIV stigma
|
2.76 units on a scale
STANDARD_DEVIATION 1.20 • n=32 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.54 units on a scale
STANDARD_DEVIATION 0.88 • n=34 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
2.65 units on a scale
STANDARD_DEVIATION 1.04 • n=66 Participants • The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%).
|
PRIMARY outcome
Timeframe: 4-5 and 6-7 months post-baselinePopulation: 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.
Percentage of doses taken, of those prescribed, from electronic monitoring
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
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Continuous Adherence (MEMS)
MEMS, 4-5 months post-baseline
|
86.7 % of doses taken, past month
Standard Deviation 16.0
|
79.0 % of doses taken, past month
Standard Deviation 23.0
|
|
Continuous Adherence (MEMS)
MEMS, 6-7 months post baseline
|
85.5 % of doses taken, past month
Standard Deviation 19.8
|
79.7 % of doses taken, past month
Standard Deviation 19.9
|
PRIMARY outcome
Timeframe: 4 and 7 months post-baselinePopulation: 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.
Percentage of doses taken, of those prescribed, self-report
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Continuous Adherence (Self-report)
4-month follow-up
|
97.48 % of doses taken, past month
Standard Deviation 5.42
|
94.57 % of doses taken, past month
Standard Deviation 6.56
|
|
Continuous Adherence (Self-report)
7-month follow-up
|
99.17 % of doses taken, past month
Standard Deviation 1.51
|
92.91 % of doses taken, past month
Standard Deviation 16.78
|
SECONDARY outcome
Timeframe: 4 and 7 months post-baselinePopulation: 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.
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
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Functional Coping Strategies
4-month follow-up
|
2.75 units on a scale
Standard Deviation 0.43
|
2.68 units on a scale
Standard Deviation 0.36
|
|
Functional Coping Strategies
7-month follow-up
|
2.82 units on a scale
Standard Deviation 0.44
|
2.74 units on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: 4 and 7 months post-baselinePopulation: 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.
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
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Positive Religious Coping Strategies
4 months post-baseline
|
1.84 units on a scale
Standard Deviation 0.85
|
2.08 units on a scale
Standard Deviation 0.65
|
|
Positive Religious Coping Strategies
7 months post-baseline
|
1.72 units on a scale
Standard Deviation 0.84
|
2.08 units on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 4 and 7 months post-baselinePopulation: 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.
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
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Dysfunctional Coping Strategies
4-month follow-up
|
2.05 units on a scale
Standard Deviation 0.33
|
2.09 units on a scale
Standard Deviation 0.41
|
|
Dysfunctional Coping Strategies
7-month follow-up
|
2.06 units on a scale
Standard Deviation 0.38
|
2.09 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 4 and 7 months post-baselinePopulation: 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.
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
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Negative Religious Coping Strategies
4 months post-baseline
|
0.17 units on a scale
Standard Deviation 0.24
|
0.34 units on a scale
Standard Deviation 0.52
|
|
Negative Religious Coping Strategies
7 months post-baseline
|
0.22 units on a scale
Standard Deviation 0.40
|
0.30 units on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 4 and 7 months post-baselinePopulation: 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.
General medical mistrust was measured with the Mistrust of Healthcare Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Medical Mistrust (General)
4 months post-baseline
|
2.34 units on a scale
Standard Deviation 0.94
|
2.78 units on a scale
Standard Deviation 0.96
|
|
Medical Mistrust (General)
7 months post-baseline
|
2.28 units on a scale
Standard Deviation 1.20
|
2.88 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 4 and 7 months post-baselinePopulation: 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.
HIV-specific medical mistrust was measured with the HIV Conspiracy Beliefs Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Medical Mistrust (HIV Conspiracy Beliefs)
4 months post-baseline
|
1.81 units on a scale
Standard Deviation 0.86
|
2.26 units on a scale
Standard Deviation 0.90
|
|
Medical Mistrust (HIV Conspiracy Beliefs)
7 months post-baseline
|
1.90 units on a scale
Standard Deviation 1.03
|
2.40 units on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: 4 and 7 months post-baselinePopulation: 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.
Internalized sexual minority stigma was assessed with the Internalized-Homophobia Scale-Revised. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Internalized Stigma (Sexual Orientation)
4 months post-baseline
|
1.53 units on a scale
Standard Deviation 0.79
|
1.59 units on a scale
Standard Deviation 0.69
|
|
Internalized Stigma (Sexual Orientation)
7 months post-baseline
|
1.68 units on a scale
Standard Deviation 1.06
|
1.59 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 4 and 7 months post-baselinePopulation: 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.
Internalized HIV stigma was assessed with the Internalized AIDS-Related Stigma Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Outcome measures
| Measure |
Siempre Seguiré
n=32 Participants
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.
|
Control
n=34 Participants
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.
|
|---|---|---|
|
Internalized Stigma (HIV)
4 months post-baseline
|
2.38 units on a scale
Standard Deviation 0.93
|
2.38 units on a scale
Standard Deviation 0.98
|
|
Internalized Stigma (HIV)
7 months post-baseline
|
2.14 units on a scale
Standard Deviation 0.90
|
2.65 units on a scale
Standard Deviation 1.17
|
Adverse Events
Siempre Seguiré
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place