Trial Outcomes & Findings for Optimal Intervention to Full Viral Suppression: Text Me, Alexis! (NCT NCT06408350)
NCT ID: NCT06408350
Last Updated: 2026-09-02
Results Overview
HIV virological suppression is defined as the undetectability threshold ˂200 copies/mL. Key indicators of HIV care will be regressed on treatment condition and a series of baseline and time-varying covariates. Responses at each timepoint will be considered nested within an individual, which is necessary to control for the violations of independence that can occur when repeated measurements are taken from the same individual.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
18 months
Results posted on
2026-09-02
Participant Flow
Participant milestones
| Measure |
Peer Health Navigation (PHN)
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
Simple Message System (SMS [Text Messaging])
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
PHN and SMS
PHN + SMS is the combined intervention.
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
23
|
|
Overall Study
COMPLETED
|
24
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Intervention to Full Viral Suppression: Text Me, Alexis!
Baseline characteristics by cohort
| Measure |
Peer Health Navigation (PHN)
n=24 Participants
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
Simple Message System (SMS [Text Messaging])
n=24 Participants
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
PHN and SMS
n=23 Participants
PHN + SMS is the combined intervention.
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 11.4 • n=136 Participants
|
50.2 years
STANDARD_DEVIATION 11.4 • n=136 Participants
|
47.6 years
STANDARD_DEVIATION 10.9 • n=272 Participants
|
49.5 years
STANDARD_DEVIATION 11.2 • n=60 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=136 Participants
|
24 Participants
n=136 Participants
|
23 Participants
n=272 Participants
|
71 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=136 Participants
|
18 Participants
n=136 Participants
|
18 Participants
n=272 Participants
|
55 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=136 Participants
|
6 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
15 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=136 Participants
|
4 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
12 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=136 Participants
|
18 Participants
n=136 Participants
|
18 Participants
n=272 Participants
|
55 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=136 Participants
|
24 participants
n=136 Participants
|
23 participants
n=272 Participants
|
71 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Trial was terminated before the outcome measure data were collected.
HIV virological suppression is defined as the undetectability threshold ˂200 copies/mL. Key indicators of HIV care will be regressed on treatment condition and a series of baseline and time-varying covariates. Responses at each timepoint will be considered nested within an individual, which is necessary to control for the violations of independence that can occur when repeated measurements are taken from the same individual.
Outcome measures
| Measure |
Peer Health Navigation (PHN)
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
Simple Message System (SMS [Text Messaging])
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
PHN and SMS
PHN + SMS is the combined intervention.
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
|---|---|---|---|
|
Rate of HIV Viral Load Suppression
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Trial was terminated before the outcome measure data were collected.
The primary outcome of the cost-effectiveness analysis is the incremental cost-effectiveness ratio (ICER), which will be calculated as the incremental mean cost of a given intervention relative to an alternative, divided by the incremental mean effectiveness of the two interventions. Two types of ICERs will be calculated, one for each measure of effectiveness: a) The quality-adjusted life-year (QALY) is a measure that combines the health-related quality-of-life (HRQoL) associated with an individual's health state and their time spent in that state, and b) Advancement along the HIV Care Continuum. All measures of mean cost and effectiveness will be adjusted for important covariates. Relative cost-effectiveness will be assessed according to multiple decision-maker perspectives, and will be evaluated across a range of willingness-to-pay thresholds.
Outcome measures
| Measure |
Peer Health Navigation (PHN)
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
Simple Message System (SMS [Text Messaging])
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
PHN and SMS
PHN + SMS is the combined intervention.
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
|---|---|---|---|
|
Relative Cost Effectiveness
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Trial was terminated before the outcome measure data were collected.
Individual-level demographic characteristics (e.g., age, race/ethnicity, time since HIV diagnosis) and treatment condition will be treated as level-2 independent variables within the hierarchical model as they are stable or intrinsic characteristics. Measurements of the social and structural determinants of health (e.g., poverty, housing/food insecurity, education, health insurance) will be included in the level-1 model as time-varying covariates because they are measured repeatedly and likely to change over the duration of the follow-up period. Lastly, an indicator of time (months since follow-up) will be included at level-1 as well. Level-2 covariates will be used to predict individual intercepts (that can be thought of as the 'starting point' for each participant), and treatment condition will be used to predict the slope of time (creating a time x intervention interaction term).
Outcome measures
| Measure |
Peer Health Navigation (PHN)
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
Simple Message System (SMS [Text Messaging])
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
PHN and SMS
PHN + SMS is the combined intervention.
PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.
Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.
Text Me, Alexis!: Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression
|
|---|---|---|---|
|
Measurements of Heterogeneous Intervention Effects
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Peer Health Navigation (PHN)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Simple Message System (SMS [Text Messaging])
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PHN and SMS
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