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

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.

Race and Ethnicity were not collected from any participant.

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.

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.

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).

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.