Trial Outcomes & Findings for Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo (NCT NCT06316102)

NCT ID: NCT06316102

Last Updated: 2026-05-22

Results Overview

Participants on antiretroviral therapy will be asked: "In the past 6 months, have you stopped or suspended your antiretrovirals?" Response options are No = No antiretroviral therapy interruption (Adherent) and Yes = Antiretroviral therapy interruption (Non-Adherent).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

124 participants

Primary outcome timeframe

6 months

Results posted on

2026-05-22

Participant Flow

Of the 124 participants who signed informed consent, one was lost to follow-up, one was found to be ineligible, and one was a duplicate (completed 2 surveys) with 121 going forward to participate in the trial.

Participant milestones

Participant milestones
Measure
Control
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Overall Study
STARTED
61
60
Overall Study
Baseline Completed
58
59
Overall Study
Midline (Month 6) Completed
43
42
Overall Study
Endline (Year 1) Completed
38
41
Overall Study
COMPLETED
38
41
Overall Study
NOT COMPLETED
23
19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=58 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=59 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Total
n=117 Participants
Total of all reporting groups
Age, Continuous
33.79 years
STANDARD_DEVIATION 11.17 • n=58 Participants
34.73 years
STANDARD_DEVIATION 9.97 • n=59 Participants
34.27 years
STANDARD_DEVIATION 10.55 • n=117 Participants
Sex/Gender, Customized
Woman
10 Participants
n=58 Participants
12 Participants
n=59 Participants
22 Participants
n=117 Participants
Sex/Gender, Customized
Trans Woman
27 Participants
n=58 Participants
24 Participants
n=59 Participants
51 Participants
n=117 Participants
Sex/Gender, Customized
Travesti
8 Participants
n=58 Participants
14 Participants
n=59 Participants
22 Participants
n=117 Participants
Sex/Gender, Customized
Transformista
10 Participants
n=58 Participants
8 Participants
n=59 Participants
18 Participants
n=117 Participants
Sex/Gender, Customized
Other
3 Participants
n=58 Participants
1 Participants
n=59 Participants
4 Participants
n=117 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Dominican Republic
58 Participants
n=58 Participants
59 Participants
n=59 Participants
117 Participants
n=117 Participants
Education Level
< High School
10 Participants
n=58 Participants
10 Participants
n=59 Participants
20 Participants
n=117 Participants
Education Level
High School
34 Participants
n=58 Participants
34 Participants
n=59 Participants
68 Participants
n=117 Participants
Education Level
> High School
14 Participants
n=58 Participants
15 Participants
n=59 Participants
29 Participants
n=117 Participants

PRIMARY outcome

Timeframe: 6 months

For viral load assessments of HIV, a 10 mL tube of ethylenediaminetetraacetic acid anti-coagulated blood will be drawn. \<400 copies/mL= viral suppression and \>=400 copies/mL= no viral suppression.

Outcome measures

Outcome measures
Measure
Control
n=43 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=42 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Number of Participants With Viral Suppression (HIV), 6 Months
31 Participants
33 Participants

PRIMARY outcome

Timeframe: 1 year

For viral load assessments of HIV, a 10 mL tube of ethylenediaminetetraacetic acid anti-coagulated blood will be drawn. \<400 copies/mL= viral suppression and \>=400 copies/mL= no viral suppression.

Outcome measures

Outcome measures
Measure
Control
n=38 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=41 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Number of Participants With Viral Suppression (HIV), 1 Year
29 Participants
34 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All collected data are reported, data are missing for participants who had never received HIV care.

Participants who have received HIV care will answer the question: "In the past 6 months, how many HIV appointments have you missed?" Response options are 0 = Retention in HIV care (i.e., Retained) and \>0 = No retention in HIV care (i.e., Not Retained).

Outcome measures

Outcome measures
Measure
Control
n=42 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=42 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Retention in HIV Care, 6 Months
Retained
35 Participants
36 Participants
Retention in HIV Care, 6 Months
Not Retained
7 Participants
6 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All collected data are reported, data are missing for participants who were unavailable or skipped answering this question.

Participants who have received HIV care will answer the question: "In the past 6 months, how many HIV appointments have you missed?" Response options are 0 = Retention in HIV care (i.e., Retained) and \>0 = No retention in HIV care (i.e., Not Retained).

Outcome measures

Outcome measures
Measure
Control
n=36 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=41 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Retention in HIV Care, 1 Year
Retained
30 Participants
30 Participants
Retention in HIV Care, 1 Year
Not Retained
6 Participants
11 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All collected data are reported, data are missing for participants who were not currently on antiretroviral therapy.

Participants on antiretroviral therapy will be asked: "During the last 4 days, how many days did you not take your entire antiretroviral therapy dose?" Response options are 0 = No antiretroviral therapy interruption (i.e., Adherent) and \>0 = Antiretroviral therapy interruption (i.e., Non-Adherent).

Outcome measures

Outcome measures
Measure
Control
n=37 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=40 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Antiretroviral Therapy Adherence, 6 Months
Non-Adherent
4 Participants
5 Participants
Antiretroviral Therapy Adherence, 6 Months
Adherent
33 Participants
35 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All collected data are reported, data are missing for participants who were not currently on antiretroviral therapy.

Participants on antiretroviral therapy will be asked: "During the last 4 days, how many days did you not take your entire antiretroviral therapy dose?" Response options are 0 = No antiretroviral therapy interruption (i.e., Adherent) and \>0 = Antiretroviral therapy interruption (i.e., Non-Adherent).

Outcome measures

Outcome measures
Measure
Control
n=35 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=36 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Antiretroviral Therapy Adherence, 1 Year
Adherent
31 Participants
33 Participants
Antiretroviral Therapy Adherence, 1 Year
Non-Adherent
4 Participants
3 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All collected data are reported, data are missing for one participant who reported never having been on antiretroviral therapy.

Participants on antiretroviral therapy will be asked: "In the past 6 months, have you stopped or suspended your antiretrovirals?" Response options are No = No antiretroviral therapy interruption (Adherent) and Yes = Antiretroviral therapy interruption (Non-Adherent).

Outcome measures

Outcome measures
Measure
Control
n=42 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=42 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Antiretroviral Therapy Interruption, 6 Months
Adherent
31 Participants
33 Participants
Antiretroviral Therapy Interruption, 6 Months
Non-Adherent
11 Participants
9 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All collected data are reported, data are missing for participants who were unavailable or skipped answering this question.

Participants on antiretroviral therapy will be asked: "In the past 6 months, have you stopped or suspended your antiretrovirals?" Response options are No = No antiretroviral therapy interruption (Adherent) and Yes = Antiretroviral therapy interruption (Non-Adherent).

Outcome measures

Outcome measures
Measure
Control
n=34 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=36 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Antiretroviral Therapy Interruption, 1 Year
Adherent
32 Participants
34 Participants
Antiretroviral Therapy Interruption, 1 Year
Non-Adherent
2 Participants
2 Participants

SECONDARY outcome

Timeframe: 6 months

The Patient Health Questionnaire (PHQ-9) is a 9-item screener to assess the frequency of depressed mood/anhedonia over the past two weeks. Participants respond to how often they have been bothered by symptoms, from 0 (not at all) to 3 (nearly every day). Scores range from 0-27, with higher scores suggestive of greater depression. Per protocol 0-9=No depressive symptoms; 10-27=depressive symptoms.

Outcome measures

Outcome measures
Measure
Control
n=43 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=42 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Depression, 6 Months
Depressive Symptoms
17 Participants
8 Participants
Depression, 6 Months
No Depressive Symptoms
26 Participants
34 Participants

SECONDARY outcome

Timeframe: 1 year

Population: All collected data are reported, data are missing for participants who were unavailable or skipped answering this question.

The Patient Health Questionnaire (PHQ-9) is a 9-item screener to assess the frequency of depressed mood/anhedonia over the past two weeks. Participants respond to how often they have been bothered by symptoms, from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27, with higher scores suggestive of greater depression. Per protocol total scores between 0-9=No depressive symptoms; and between 10-27=depressive symptoms.

Outcome measures

Outcome measures
Measure
Control
n=36 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=41 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Depression, 1 Year
Depressive Symptoms
6 Participants
8 Participants
Depression, 1 Year
No Depressive Symptoms
30 Participants
33 Participants

SECONDARY outcome

Timeframe: 6 months

The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that includes two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D), each rated on a 0-3 scale. For this study only HADS-A subscale was used. Raw scores range from 0-21 with higher scores indicating higher anxiety. Per protocol, scores from 0-7 = no anxiety symptoms, scores from 8-21 = anxiety symptoms.

Outcome measures

Outcome measures
Measure
Control
n=43 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=42 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Anxiety, 6 Months
Anxiety symptoms
13 Participants
18 Participants
Anxiety, 6 Months
No anxiety symptoms
30 Participants
24 Participants

SECONDARY outcome

Timeframe: 1 year

The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that includes two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D), each rated on a 0-3 scale. For this study only HADS-A subscale was used. Raw scores range from 0-21 with higher scores indicating higher anxiety. Per protocol, scores from 0-7 = no anxiety symptoms, scores from 8-21 = anxiety symptoms.

Outcome measures

Outcome measures
Measure
Control
n=38 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=41 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Anxiety, 1 Year
Anxiety symptoms
20 Participants
16 Participants
Anxiety, 1 Year
No anxiety symptoms
18 Participants
25 Participants

SECONDARY outcome

Timeframe: 6 months

Population: All collected data are reported, data are missing for participants who were unavailable or skipped answering this question.

Participants were asked a series of questions about illicit substance use in the previous 6 months. Options were: Yes = used any type of illicit drug in the previous 6 months and No = did not use any type of illicit drug in the previous 6 months.

Outcome measures

Outcome measures
Measure
Control
n=39 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=39 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Substance Use, 6 Months
Used illicit drug(s)
16 Participants
18 Participants
Substance Use, 6 Months
Did not use illicit drug(s)
23 Participants
21 Participants

SECONDARY outcome

Timeframe: 1 year

Participants were asked a series of questions about illicit substance use in the previous 6 months. Options were: Yes = used any type of illicit drug in the previous 6 months and No = did not use any type of illicit drug in the previous 6 months.

Outcome measures

Outcome measures
Measure
Control
n=38 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=41 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Substance Use, 1 Year
Used illicit drug(s)
16 Participants
12 Participants
Substance Use, 1 Year
Did not use illicit drug(s)
22 Participants
29 Participants

SECONDARY outcome

Timeframe: 6 months

Participants were asked about binge drinking. Binge drinking was defined per protocol as 6 or more drinks on one occasion. Options were: Yes = consume 6+ drinks on one occasion at least monthly and No = consumes 6+ drinks on one occasion less than once a month.

Outcome measures

Outcome measures
Measure
Control
n=43 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=42 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Binge Drinking, 6 Months
Did not engage in binge drinking
27 Participants
27 Participants
Binge Drinking, 6 Months
Engaged in binge drinking
16 Participants
15 Participants

SECONDARY outcome

Timeframe: 1 year

Participants were asked about binge drinking. Binge drinking was defined per protocol as 6 or more drinks on one occasion. Options were: Yes = consume 6+ drinks on one occasion at least monthly and No = consumes 6+ drinks on one occasion less than once a month.

Outcome measures

Outcome measures
Measure
Control
n=38 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=41 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Binge Drinking, 1 Year
Engaged in binge drinking
16 Participants
25 Participants
Binge Drinking, 1 Year
Did not engage in binge drinking
22 Participants
16 Participants

SECONDARY outcome

Timeframe: 6 months

The Rosenberg self-esteem scale is a 10-item Likert-type scale that assesses participants' self-esteem. As used in this study, the total scale score range from 0-30, where higher scores indicate greater self-esteem. Response options were: Totally agree = 3, Agree = 2, Disagree = 1, and Totally disagree = 0.

Outcome measures

Outcome measures
Measure
Control
n=43 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=42 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Self-esteem, 6 Months
19.605 score on a scale
Standard Deviation 4.107
19.738 score on a scale
Standard Deviation 4.632

SECONDARY outcome

Timeframe: 1 year

The Rosenberg self-esteem scale is a 10-item Likert-type scale that assesses participants' self-esteem. As used in this study, the total scale score range from 0-30, where higher scores indicate greater self-esteem. Response options were: Totally agree = 3, Agree = 2, Disagree = 1, and Totally disagree = 0.

Outcome measures

Outcome measures
Measure
Control
n=38 Participants
This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
n=41 Participants
This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building. Gender Affirming Abriendo Puertas (Opening Doors) (GAP): Multilevel intervention with 4 components
Self-esteem, 1 Year
19.947 score on a scale
Standard Deviation 3.631
19.756 score on a scale
Standard Deviation 3.793

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Gender Affirming Abriendo Puertas (Opening Doors) (GAP)

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

Clare Barrington, PhD, MPH

University of North Carolina at Chapel Hill

Phone: 919-966-9009

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place