Trial Outcomes & Findings for The BRIgHT Program: Building Resilience in HIV Together (NCT NCT03673098)

Last Updated: 2022-05-13

Results Overview

Investigators assessed feasibility of study procedures by tracking the number of potential participants screened and eligible for participation. These metrics were assessed together with the number of eligible individuals enrolled, and the number of assessments completed in order to provide a comprehensive understanding of the feasibility of this study.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

Assessed at screening (pre-baseline)

Results posted on

2022-05-13

Participant Flow

Participants were recruited from Boston-area hospitals and healthcare settings between October 2018 and July 2020. The first participant was enrolled on November 5, 2018 and the last participant was enrolled in July 10, 2020.

Of the 65 participants screened, 61 met inclusion criteria, and 44 were consented, enrolled and randomized to either the intervention arm or the control arm.

Participant milestones

Participant milestones
Measure	Intervention Group: Adapted 3RP The intervention condition will consist of the 10-week adapted 3RP intervention. Adapted 3RP: The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot).	Control Group: Supportive Psychotherapy The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.
Overall Study STARTED	23	21
Overall Study COMPLETED	13	17
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group: Adapted 3RP The intervention condition will consist of the 10-week adapted 3RP intervention. Adapted 3RP: The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot).	Control Group: Supportive Psychotherapy The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.
Overall Study Lost to Follow-up	2	3
Overall Study Withdrawal by Subject	6	1
Overall Study Could not participate due to scheduling conflicts or health issues	2	0

Baseline Characteristics

The BRIgHT Program: Building Resilience in HIV Together

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group: Adapted 3RP n=23 Participants The intervention condition will consist of the 10-week adapted 3RP intervention. Adapted 3RP: The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot).	Control Group: Supportive Psychotherapy n=21 Participants The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Total n=44 Participants Total of all reporting groups
Age, Continuous	57.6 years n=5 Participants	59.2 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	21 participants n=7 Participants	44 participants n=5 Participants
Education Level No formal education	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Education Level Eighth grade or lower	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Education Level Some high school	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Education Level High school graduate or GED	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Education Level Some college/Associate degree/technical school	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Education Level College graduate (BA/BS)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Education Level Some graduate school	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Education Level Master's degree	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Education Level Doctorate/Medical degree/Law degree	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Education Level Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Employment Status Full-time employed	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Employment Status Part-time Employed	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Employment Status Full-time or part-time in school	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Employment Status Neither employed nor in school/ Retired	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Employment Status On disability	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Employment Status Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Annual Income $10,000 or less	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Annual Income $10,001 to $20,000	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Annual Income $20,001 to $40,000	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Annual Income $40,001 to $60,000	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Annual Income $60,001 to $80,000	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Annual Income Over $80,000	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Annual Income Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Time Since HIV Diagnosis	25 years n=5 Participants	27 years n=7 Participants	26 years n=5 Participants

PRIMARY outcome

Timeframe: Assessed at screening (pre-baseline)

Population: 65 total participants were recruited and screened for eligibility. 61 participants were deemed eligible based on inclusion criteria; 4 were ineligible.

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=65 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall Total participants (includes both control and intervention)
Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study Eligible	61 Participants	—	—
Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study Ineligible: Not a cisgender woman	3 Participants	—	—
Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study Ineligible: Not living with HIV	1 Participants	—	—

PRIMARY outcome

Timeframe: Assessed up to 6 months post-baseline

Population: Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.

Investigators assessed feasibility of study procedures by tracking the number of eligible participants enrolled, and the number of treatment, assessment, and make-up sessions completed by all enrolled participants. These metrics were assessed together with the number of individuals screened and eligible in order to provide a comprehensive understanding of the feasibility of this study.

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=23 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy n=21 Participants The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall Total participants (includes both control and intervention)
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. Participated in group sessions	20 Participants	21 Participants	—
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. Attended at least 70% of group sessions	15 Participants	15 Participants	—
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. Completed post-treatment assessment	16 Participants	18 Participants	—
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. Completed qualitative exit interview	15 Participants	18 Participants	—
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. Completed 3-month follow-up assessment	13 Participants	17 Participants	—
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. Completed COVID-19 quantitative assessment	13 Participants	15 Participants	—
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. Completed COVID-19 qualitative interview	10 Participants	14 Participants	—

PRIMARY outcome

Timeframe: Assessed after completion of all baseline assessments

Population: Enrollment was expected to begin in April 2018 and end in March 2019, but began instead in October 2018 and ended in July 2020. Total target enrollment for Aim 2 was 60 participants. A total of 65 individuals were screened, 61 were eligible, and 44 were consented/enrolled.

Investigators assessed feasibility of study procedures by tracking the time it takes to screen and enroll participants, as measured by the number of months it took to recruit, screen, and schedule a baseline assessment for all 44 participants, compared to the number of months we estimated it would take to enroll our target number of participants at the outset of the study (11 months). These metrics were assessed in order to provide a comprehensive understanding of the feasibility of this study.

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=44 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall Total participants (includes both control and intervention)
Feasibility of Study Procedures, as Assessed by Time Required for Screening and Enrollment Planned duration of screening and enrollment	11 months	—	—
Feasibility of Study Procedures, as Assessed by Time Required for Screening and Enrollment Actual duration of screening and enrollment	21 months	—	—

PRIMARY outcome

Timeframe: Assessed up to 6 months post-baseline

Population: Note: Not at all participants in the study completed all time point assessments and/or qualitative interviews. Average time taken to complete the following assessments is based on the specific number of individuals that completed the specific time point assessment rather than the total number of participants enrolled (N=44).

Investigators assessed feasibility of study procedures by tracking the time it takes for participants to complete each assessment. These metrics were assessed in order to provide a comprehensive understanding of the feasibility of this study.

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=23 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy n=21 Participants The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall n=44 Participants Total participants (includes both control and intervention)
Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures Baseline assessment	94.9 minutes Interval 36.0 to 203.0	94.6 minutes Interval 39.0 to 184.0	94.8 minutes Interval 36.0 to 203.0
Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures Post-treatment assessment	86.7 minutes Interval 33.0 to 165.0	84.3 minutes Interval 33.0 to 160.0	85.4 minutes Interval 33.0 to 165.0
Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures 3-month follow-up assessment	93.2 minutes Interval 45.0 to 278.0	70.3 minutes Interval 29.0 to 138.0	80.9 minutes Interval 29.0 to 278.0

PRIMARY outcome

Timeframe: Assessed at screening (pre-baseline)

Population: 65 total participants were recruited and screened for eligibility at the outset of the study. 61 were deemed eligible to participate prior to randomization.

Includes the number of individuals who were eligible (N=61), but declined to enroll and those reasons for declining.

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=17 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall Total participants (includes both control and intervention)
Feasibility as Assessed by Reasons for Declining Enrollment Lack of interest	1 Participants	—	—
Feasibility as Assessed by Reasons for Declining Enrollment Scheduling conflicts	2 Participants	—	—
Feasibility as Assessed by Reasons for Declining Enrollment Reason unknown	14 Participants	—	—

PRIMARY outcome

Timeframe: Assessed up to 3 months post-baseline

Population: Participants who enrolled but did not attend group sessions (n=2) were part of the intervention arm only (n=2); no participants who enrolled but did not attend group sessions were part of the control arm (n=0). Therefore, the "Overall Number of Participants Analyzed" below are 2 and 0 for the intervention and control arms, respectively, with reasons defined for not taking part in group sessions.

Includes the number of individuals who enrolled, but did not take part in group sessions (N=2) and the reasons for not participating.

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=2 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall n=2 Participants Total participants (includes both control and intervention)
Feasibility as Assessed by Reasons for Enrolling But Not Taking Part in Group Sessions Scheduling conflicts	1 Participants	0 Participants	1 Participants
Feasibility as Assessed by Reasons for Enrolling But Not Taking Part in Group Sessions Health issues	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Assessed up to 6 months post-baseline

Population: Participants who withdrew from the study (n=7) were part of both the intervention arm (n=6) and the control arm (n=1). Therefore, the "Overall Number of Participants Analyzed" below are 6 and 1 for the intervention and control arms, respectively, with reasons for withdrawing participation defined.

Includes the number of individuals who withdrew from the study, despite participating in group sessions (N=7), and the reasons for withdrawing.

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=6 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy n=1 Participants The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall n=7 Participants Total participants (includes both control and intervention)
Feasibility as Assessed by Reasons for Withdrawing From the Study Scheduling conflicts	1 Participants	0 Participants	1 Participants
Feasibility as Assessed by Reasons for Withdrawing From the Study Health issues	2 Participants	0 Participants	2 Participants
Feasibility as Assessed by Reasons for Withdrawing From the Study Lack of privacy	0 Participants	1 Participants	1 Participants
Feasibility as Assessed by Reasons for Withdrawing From the Study Reimbursement issues	1 Participants	0 Participants	1 Participants
Feasibility as Assessed by Reasons for Withdrawing From the Study Reasons unknown	2 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Assessed up to 6 months post-baseline

Population: The "Overall Number of Participants Analyzed" below reflect the number of enrolled participants in each study arm. Participants who were lost to follow-up (n=5) were part of both the intervention arm (n=2) and the control arm (n=3).

Includes the number of individuals who were lost to follow-up and unable to be traced (N=5).

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=23 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy n=21 Participants The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall n=44 Participants Total participants (includes both control and intervention)
Feasibility as Assessed by Participants Lost to Follow-Up	2 Participants	3 Participants	5 Participants

PRIMARY outcome

Timeframe: Assessed up to 6 months post-baseline

Population: CSQ-8 scores were collected at the post-treatment assessment; therefore, the "Overall Number of Participants Analyzed" reflects the total number of participants that completed a post-treatment assessment (N=33 overall; N=15 in intervention arm; N=18 in control arm).

Investigators assessed acceptability at the post-treatment visit using the eight-item Client Satisfaction Questionnaire (CSQ-8), a measure of how much an individual values a treatment. Items are summed to create an overall score; scores range from 8 to 32, with higher scores indicating higher satisfaction. Excellent acceptability was defined a priori as CSQ-8 scores between 26 and 32, and good acceptability was defined a priori as CSQ-8 scores between 20 and 25.

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=15 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy n=18 Participants The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall n=33 Participants Total participants (includes both control and intervention)
Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire	20.6 score on a scale Standard Deviation 4.3	20.3 score on a scale Standard Deviation 3.5	20.4 score on a scale Standard Deviation 3.8

PRIMARY outcome

Timeframe: Assessed up to 6 months post-baseline

Population: Perception of Study Assessment scores were collected at the post-treatment assessment; therefore, the "Overall Number of Participants Analyzed" reflects the total number of participants that completed a post-treatment assessment (N=33 overall; N=15 in intervention arm; N=18 in control arm).

Investigators assessed acceptability at the post-treatment visit by asking participants about their perceptions of the burden of the study assessment battery on a scale from 1 ("no/minimal burden") to 10 ("too much of a burden"). Items are summed to create an overall score; scores range from 1 to 10, with lower scores indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	Total Recruitment Population n=15 Participants Feasibility was defined a priori, and was considered met if: (1) ≥ 70% of eligible individuals enrolled in the study; (2) ≥ 7 out of 10 group sessions were attended by ≥ 70% of participants; and (3) ≥ 2 assessments were completed by ≥ 70% of participants.	Control Group: Supportive Psychotherapy n=18 Participants The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.	Overall n=33 Participants Total participants (includes both control and intervention)
Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire "No/minimal burden" (score = 1)	11 Participants	9 Participants	20 Participants
Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire "Too much of a burden" (score = 10)	1 Participants	1 Participants	2 Participants
Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire Between "No/minimal burden" and "Moderate burden" (score = 2-4)	1 Participants	6 Participants	7 Participants
Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire Between "Moderate burden" and "Too much of a burden" (score = 5-9)	2 Participants	2 Participants	4 Participants

Adverse Events

Intervention Group: Adapted 3RP

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group: Supportive Psychotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Group: Adapted 3RP n=23 participants at risk The intervention condition will consist of the 10-week adapted 3RP intervention. Adapted 3RP: The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot).	Control Group: Supportive Psychotherapy n=21 participants at risk The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.
Psychiatric disorders Admission to Emergency Department, Unrelated to Study	4.3% 1/23 • Number of events 1 • Up to 6 months post-baseline	0.00% 0/21 • Up to 6 months post-baseline

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christina Psaros

Massachusetts General Hospital

Phone: 617-726-7458

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place