HIV
Conditions
Keywords
transgender women, transfeminine people, HIV, Stigma, Cohesion, Multilevel intervention
Brief summary
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).
Interventions
BEHAVIORALGender Affirming Abriendo Puertas (Opening Doors) (GAP)
Multilevel intervention with 4 components
Sponsors
University of North Carolina, Chapel Hill
Instituto Dermatológico y Cirugía de Piel (IDCP)
George Washington University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* being at least 18 years of age; * assigned male at birth but self-identify as transfeminine (using locally appropriate terminology); * confirmed HIV positive diagnosis using a single rapid test
Exclusion criteria
* There is a small group of individuals (approximately 20) who participated in a previous adaptation study to develop the intervention that will be tested in the proposed study. These individuals will not be eligible since they have already been exposed to an earlier version of the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Viral Suppression (HIV), 6 Months | 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. |
| Number of Participants With Viral Suppression (HIV), 1 Year | 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. |
| Retention in HIV Care, 6 Months | 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). |
| Retention in HIV Care, 1 Year | 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). |
| 4-day Antiretroviral Therapy Adherence, 6 Months | 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). |
| 4-day Antiretroviral Therapy Adherence, 1 Year | 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). |
| 6-month Antiretroviral Therapy Interruption, 6 Months | 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-month Antiretroviral Therapy Interruption, 1 Year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression, 6 Months | 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. |
| Depression, 1 Year | 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. |
| Anxiety, 6 Months | 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. |
| Anxiety, 1 Year | 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. |
| Substance Use, 6 Months | 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. |
| Substance Use, 1 Year | 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. |
| Binge Drinking, 6 Months | 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. |
| Binge Drinking, 1 Year | 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. |
| Self-esteem, 6 Months | 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. |
| Self-esteem, 1 Year | 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. |
Countries
Dominican Republic
Contacts
PRINCIPAL_INVESTIGATORClare Barrington, PhD
University of North Carolina, Chapel Hill
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.73 years STANDARD_DEVIATION 9.97 |
| Education Level < High School | 10 Participants |
| Education Level > High School | 29 Participants |
| Education Level High School | 34 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Dominican Republic | 58 Participants |
| Sex/Gender, Customized Other | 4 Participants |
| Sex/Gender, Customized Transformista | 10 Participants |
| Sex/Gender, Customized Trans Woman | 27 Participants |
| Sex/Gender, Customized Travesti | 8 Participants |
| Sex/Gender, Customized Woman | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 60 |
| other Total, other adverse events | 0 / 61 | 0 / 60 |
| serious Total, serious adverse events | 0 / 61 | 0 / 60 |
Outcome results
None listed