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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH129218 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Instituto Dermatológico y Cirugía de Piel (IDCP) | UNKNOWN |
| George Washington University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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This study includes an adapted multilevel intervention, Abriendo Puertas (Opening Doors), including individual counseling, peer navigation, and community mobilization for transfeminine people living with HIV in the Dominican Republic using an iterative consultation process. Prior to this randomized controlled trial, feasibility and initial effects on HIV care and treatment behaviors were assessed with 30 trans women living with HIV (no control group) and documented positive trends in antiretroviral therapy use (70% to 85%, p=0.03), missed care appointments (35% to 20%, p=0.39) and antiretroviral therapy adherence (86% to 96%, p=0.50). Participants emphasized that trusting intervention staff and being treated with respect in individual sessions allowed them to improve self-esteem. Limited trust and cohesion among trans women, however, inhibited more extensive engagement with peer navigation and community activities. In response, the study team identified two key modifications to strengthen and further tailor the intervention for transfeminine people living with HIV: 1) integrate more gender affirming content, including with providers and 2) focus on building trust among transfeminine people through sequential implementation of individual and then community components. The purpose of the proposed study is to conduct a pilot randomized trial of the Gender-affirming Abriendo Puertas intervention. In Aim 1, the preliminary efficacy of the Gender-affirming Abriendo Puertas intervention on viral suppression among transfeminine people randomized to the intervention compared to those randomized to control will be assessed. The research study will randomly assign transfeminine people living with HIV to the Gender-affirming Abriendo Puertas intervention (n=60) (individual counseling, peer navigation, provider training, and community support building) or control group (n=60). There will be baseline, 6, and 12-month surveys and viral load assessments to assess differences across study arms. In Aim 2, the study team will examine pathways of influence (e.g. decreased stigma, increased cohesion) and experiences with the intervention to identify specific areas for improvement and scale up. Longitudinal qualitative interviews will be conducted at baseline, 6, and 12 months with 20 intervention participants. Together with surveys, the study team will assess how Gender-affirming Abriendo Puertas participation affects pathways between stigma, cohesion, and HIV outcomes. The study team will also elicit experiences and recommendations from providers and intervention staff in focus groups at 6 (n=2) and 12 months (n=2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | This group will not receive an intervention; control participants may be exposed to providers who participated in a training on gender-affirming care. | |
| Gender Affirming Abriendo Puertas (Opening Doors) (GAP) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gender Affirming Abriendo Puertas (Opening Doors) (GAP) | Behavioral | Multilevel intervention with 4 components |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Viral Suppression (HIV), 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. | 6 months |
| Number of Participants With Viral Suppression (HIV), 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. | 1 year |
| Retention in HIV Care, 6 Months | 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). | 6 months |
| Retention in HIV Care, 1 Year | 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). | 1 year |
| 4-day Antiretroviral Therapy Adherence, 6 Months | Participants currently 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). | 6 months |
| 4-day Antiretroviral Therapy Adherence, 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Depression, 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. |
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Inclusion Criteria:
Exclusion Criteria:
Participants must have a transfeminine identity.
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| Name | Affiliation | Role |
|---|---|---|
| Clare Barrington, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dermatológico y Cirugía de Piel (IDCP) | Santo Domingo | Dominican Republic |
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Of the 124 participants who signed informed consent, 3 were excluded due to ineligible or unfeasible participation. 121 participants were randomly assigned to either the control or intervention (Gender Affirming Abriendo Puertas) group. 18 providers/staff were also enrolled as secondary participants for focus groups (not randomized and did not receive an intervention). Total = 139. This was not a cluster-randomized study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | This group will not receive an intervention; control participants may be exposed to providers who participated in a training on gender-affirming care. |
| FG001 | 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 |
| FG002 | Providers and Staff | Providers and Staff employed at the Servicio de Atención Integral (SAI) clinics who participated in the capacity building on gender-affirming care conducted at Midline (Month 6). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | This group will not receive an intervention; control participants may be exposed to providers who participated in a training on gender-affirming care. |
| BG001 | Gender Affirming Abriendo Puertas (Opening Doors) (GAP) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Viral Suppression (HIV), 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. | Posted | Count of Participants | Participants | 6 months |
|
From the time of signing informed consent through the Month 12 visit, up to 18 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | This group will not receive an intervention; control participants may be exposed to providers who participated in a training on gender-affirming care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clare Barrington, PhD, MPH | University of North Carolina at Chapel Hill | 919-966-9009 | cbarring@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2025 | Nov 3, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2026 | Apr 17, 2026 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 21, 2023 | Sep 2, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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Participants currently 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). |
| 1 year |
| 6-month Antiretroviral Therapy Interruption, 6 Months | Participants who reported ever having taken 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). | 6 months |
| 6-month Antiretroviral Therapy Interruption, 1 Year | 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). | 1 year |
| 6 months |
| Depression, 1 Year | 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. | 1 year |
| Anxiety, 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. | 6 months |
| Anxiety, 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. | 1 year |
| Substance Use, 6 Months | 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. | 6 months |
| Substance Use, 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. | 1 year |
| Binge Drinking, 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. | 6 months |
| Binge Drinking, 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. | 1 year |
| Self-esteem, 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. | 6 months |
| Self-esteem, 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. | 1 year |
| Change in eligibility status |
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| Protocol Violation |
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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
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Education Level | Count of Participants | Participants |
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| Primary | Number of Participants With Viral Suppression (HIV), 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. | Posted | Count of Participants | Participants | 1 year |
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| Primary | Retention in HIV Care, 6 Months | 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). | All collected data are reported, data are missing for participants who had never received HIV care. | Posted | Count of Participants | Participants | 6 months |
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| Primary | Retention in HIV Care, 1 Year | 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). | All collected data are reported, data are missing for participants who were unavailable or skipped answering this question. | Posted | Count of Participants | Participants | 1 year |
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| Primary | 4-day Antiretroviral Therapy Adherence, 6 Months | Participants currently 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). | All collected data are reported; however, data collection was restricted to participants who were currently receiving antiretroviral therapy (ART) at Month 6, due to outcome-specific question design assessing only those on ART at the time of evaluation. Accordingly, the number of participants included in this analysis may differ from outcomes assessing all participants. | Posted | Count of Participants | Participants | 6 months |
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| Primary | 4-day Antiretroviral Therapy Adherence, 1 Year | Participants currently 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). | All collected data are reported, data are missing for participants who were not currently on antiretroviral therapy. | Posted | Count of Participants | Participants | 1 year |
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| Primary | 6-month Antiretroviral Therapy Interruption, 6 Months | Participants who reported ever having taken 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). | All collected data are reported. This outcome includes participants who reported ever receiving antiretroviral therapy (ART) at the Month 6 visit, including those not currently on ART; data were not collected for participants who reported never having received ART (n=1 in the Control arm). | Posted | Count of Participants | Participants | 6 months |
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| Primary | 6-month Antiretroviral Therapy Interruption, 1 Year | 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). | All collected data are reported, data are missing for participants who were unavailable or skipped answering this question. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Depression, 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. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Depression, 1 Year | 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. | All collected data are reported, data are missing for participants who were unavailable or skipped answering this question. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Anxiety, 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. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Anxiety, 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. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Substance Use, 6 Months | 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. | All collected data are reported, data are missing for participants who were unavailable or skipped answering this question. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Substance Use, 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. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Binge Drinking, 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. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Binge Drinking, 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. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Self-esteem, 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Self-esteem, 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. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
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| 0 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | 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 | 0 | 60 | 0 | 60 | 0 | 60 |
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