Trial Outcomes & Findings for Improving HIV Outcomes Among African American Transgender Women (NCT NCT05483686)
NCT ID: NCT05483686
Last Updated: 2023-10-16
Results Overview
Percentage of participants with a composite risk for HIV score of 1. The composite risk for HIV score combines participants' use of and adherence to biomedical and behavioral strategies over the past month into a binary indicator (0, 1) of HIV acquisition or transmission risk. 0 indicates some HIV transmission risk and 1 indicates no HIV transmission risk.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2023-10-16
Participant Flow
Data were collected from 11/16/2021 - 1/30/2023 via telephone with participants recruited through online advertising
Of the 83 potential participants assessed for eligibility, 33 did not meet eligibility criteria and 12 did not return our calls to complete informed consent and enroll in the study.
Participant milestones
| Measure |
Shine Intervention
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Shine Intervention
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
Baseline Characteristics
Improving HIV Outcomes Among African American Transgender Women
Baseline characteristics by cohort
| Measure |
Shine Intervention
n=18 Participants
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
n=20 Participants
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.17 years
STANDARD_DEVIATION 9.20 • n=99 Participants
|
35.90 years
STANDARD_DEVIATION 10.13 • n=107 Participants
|
37.45 years
STANDARD_DEVIATION 9.71 • n=206 Participants
|
|
Sex/Gender, Customized
Transgender Woman
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
20 participants
n=107 Participants
|
38 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Percentage of participants with a composite risk for HIV score of 1. The composite risk for HIV score combines participants' use of and adherence to biomedical and behavioral strategies over the past month into a binary indicator (0, 1) of HIV acquisition or transmission risk. 0 indicates some HIV transmission risk and 1 indicates no HIV transmission risk.
Outcome measures
| Measure |
Shine Intervention
n=13 Participants
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
n=13 Participants
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Change in Percentage of Participants With HIV Transmission Risk at Month 6
Baseline
|
23.077 percentage of participants with no risk
|
38.462 percentage of participants with no risk
|
|
Change in Percentage of Participants With HIV Transmission Risk at Month 6
Month 6
|
46.154 percentage of participants with no risk
|
46.154 percentage of participants with no risk
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Subsample of participants who completed the ART adherence measure (i.e., those who reported being currently prescribed ART).
ART adherence was measured using the 8-item Morisky Medication Adherence Scale (MMAS-8). Total scores range from 0 ot 8 with higher scores indicating better adherence.
Outcome measures
| Measure |
Shine Intervention
n=6 Participants
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
n=5 Participants
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Change in ART Adherence at Month 6
Baseline
|
3.38 score on a scale
Standard Deviation 2.17
|
5.25 score on a scale
Standard Deviation 1.26
|
|
Change in ART Adherence at Month 6
Month 6
|
6.50 score on a scale
Standard Deviation 1.29
|
6.50 score on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Baseline and Month 6Percentage of anal sex acts in the past month during which a condom was used
Outcome measures
| Measure |
Shine Intervention
n=13 Participants
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
n=13 Participants
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Change in Condom Use at Month 6
Month 6
|
37.33 percentage of sex acts with condom
Standard Deviation 50.40
|
58.84 percentage of sex acts with condom
Standard Deviation 41.74
|
|
Change in Condom Use at Month 6
Baseline
|
51.79 percentage of sex acts with condom
Standard Deviation 36.68
|
49.39 percentage of sex acts with condom
Standard Deviation 40.54
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Subsample of participants who completed the ART barriers measure (i.e., those who reported being currently prescribed ART).
ART Barriers were measured with a 14-item measure developed by the Adult AIDS Clinical Trials Group; items rated on 0-4 Likert-type scale where higher scores indicate more barriers to ART use; min=0 and max=4 (averaged)
Outcome measures
| Measure |
Shine Intervention
n=6 Participants
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
n=5 Participants
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Change in Barriers to ART Use at Month 6
Baseline
|
1.02 units on a scale
Standard Deviation .79
|
1.04 units on a scale
Standard Deviation .41
|
|
Change in Barriers to ART Use at Month 6
Month 6
|
.70 units on a scale
Standard Deviation .51
|
.86 units on a scale
Standard Deviation .68
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Subsample of participants who completed the PrEP barriers measure (i.e., those who reported being HIV-negative or of unknown HIV status).
12 item scale (multiple choice) for HIV-negative or unknown status participants; items rated on 0-4 Likert-type scale where higher scores indicate more barriers to PrEP use; min=0 and max=4 (averaged)
Outcome measures
| Measure |
Shine Intervention
n=6 Participants
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
n=7 Participants
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Change in Barriers to PrEP Use at Month 6
Baseline
|
2.62 score on a scale
Standard Deviation 1.07
|
2.02 score on a scale
Standard Deviation 1.39
|
|
Change in Barriers to PrEP Use at Month 6
Month 6
|
2.18 score on a scale
Standard Deviation .97
|
2.13 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: Baseline and Month 629-item scale (multiple choice); items rated on 0-4 Likert-type scale where higher scores indicate more barriers to condom use; min=0 and max=4 (averaged)
Outcome measures
| Measure |
Shine Intervention
n=12 Participants
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
n=13 Participants
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Change in Barriers to Condom Use at Month 6
Baseline
|
1.20 units on a scale
Standard Deviation .68
|
1.09 units on a scale
Standard Deviation .97
|
|
Change in Barriers to Condom Use at Month 6
Month 6
|
1.05 units on a scale
Standard Deviation .94
|
.76 units on a scale
Standard Deviation .79
|
SECONDARY outcome
Timeframe: Baseline and Month 6the 19-item Social Support Scale from the Medical Outcomes Study (multiple choice); items rated on 0-4 Likert-type scale where higher scores indicate greater social support; min=0 and max=4 (averaged)
Outcome measures
| Measure |
Shine Intervention
n=13 Participants
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
n=13 Participants
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Change in Social Support at Month 6
Baseline
|
2.57 units on a scale
Standard Deviation 1.06
|
2.68 units on a scale
Standard Deviation 1.09
|
|
Change in Social Support at Month 6
Month 6
|
2.86 units on a scale
Standard Deviation .94
|
2.53 units on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline and Month 6measured using the 12-item Transgender Congruence Scale; 12 item scale (multiple choice); items rated on 0-4 Likert-type scale where higher scores indicate greater gender identity comfort; min=0 and max=4 (averaged)
Outcome measures
| Measure |
Shine Intervention
n=13 Participants
Experimental group participants will have access to the mobile Shine intervention.
Shine: This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. We envision the proposed intervention being used by clinics and community-based organizations that serve transgender women.
|
Control Videos
n=13 Participants
Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).
Control: A playlist of CDC-developed videos designed to provide information on HIV for transgender women
|
|---|---|---|
|
Change in Gender Identity Comfort at Month 6
Baseline
|
3.13 units on a scale
Standard Deviation .72
|
3.12 units on a scale
Standard Deviation .79
|
|
Change in Gender Identity Comfort at Month 6
Month 6
|
3.17 units on a scale
Standard Deviation .70
|
3.13 units on a scale
Standard Deviation 1.09
|
Adverse Events
Shine Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Videos
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place