Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05483686 |
| Other study ID # |
R44MH117837 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2021 |
| Est. completion date |
January 30, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
ISA Associates, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators will conduct a randomized controlled trial to test the efficacy of the
mobile HIV behavioral intervention for African American transgender women (Shine).
Participants will be 215 trans women recruited by staff of the Trans Women of Color
Collective via community events and social media. Participants must : 1) identify as a Black
transgender woman using the 2-step method (Step 1: assigned male birth sex, Step 2: current
gender identity is female); 2) be aged 18 or older; 3) report risk of HIV transmission in
past 3 months (i.e., CAS with a serodiscordant or risky partner AND either <90% ART adherence
or <5 daily doses of PrEP per week); 4) own a smartphone; and 5) be able to read and speak
English. Eligible participants who subsequently provide informed consent will complete two
confidential phone-based research surveys at different time points (baseline and 6 months
post-baseline) and will be randomly assigned to one of two conditions (Shine or mobile HIV
education for transgender women).
Participants randomly assigned to the experimental condition will be instructed to text the
word "Join" to the Shine study phone number. The intervention will take approximately 1-2
hours, with content delivered over several weeks. Participants randomly assigned to the
control condition will be texted a link to a set of videos on healthy HIV-related behaviors
for transgender women. These videos cover a variety of topics, including recommended testing
frequencies, PrEP, and ART.
After randomization, participants will complete the baseline research survey. This survey
will assess the primary outcome of composite HIV transmission risk along with several
secondary outcomes (individual behavioral components of the composite score; HIV medical care
utilization and adherence; HIV testing; PrEP knowledge, interest, and uptake; gender
affirmation; well-being; social support; sexual communication). Six months after the baseline
research survey, all participants will complete a follow-up research survey assessing the
same outcome measures in the baseline research survey.
Binomial logistic regression will be the main analytic technique for the primary measure
(composite risk for HIV transmission). For the secondary continuous measures, hierarchical
linear modeling (HLM) will be used. All models will control for any demographic covariate
(e.g., age) that varies at the .2 significance level due to randomization failure at
baseline.
Description:
The investigators will conduct a randomized controlled trial to test the efficacy of Shine,
an mHealth HIV behavioral intervention for African American transgender women (TGW).
Participants will be 215 African American TGW recruited by Trans Women of Color Collective
(TWOCC) via in-person and online recruitment strategies. First, TWOCC's leadership and
administrative teams will distribute palm cards and display posters describing the study
during all community-based events that occur during the recruitment period. Second, ISA and
TWOCC will develop an online strategy to disseminate a study flyer via social media (e.g.,
Facebook, Twitter). The flyer will be posted on both social media channels weekly during the
study recruitment period. Interested women recruited via either method (in-person or online)
will be instructed to contact the ISA field test manager for more information and to complete
eligibility screening.
Interested participants who contact the field test manager will complete an eligibility
screener. Specifically, participants must : 1) identify as a Black transgender woman using
the recommended 2-step method (Step 1: assigned male birth sex, Step 2: current gender
identity is female); 2) be aged 18 or older; 3) report risk of HIV transmission in the past 3
months (i.e., CAS with a serodiscordant or risky male partner AND either <90% ART adherence
or <5 daily doses of PrEP per week); 4) own a smartphone; and 5) be able to read and speak
English.
Ineligible women will be thanked, dismissed, and offered alternatives to the type of
information being offered in this research study. Eligible women will provide contact
information receive a detailed overview of the main points of the study. Once any participant
questions are answered, the field test manager will trigger a text to be sent to the
potential participant's study phone number. The text will include a link to an online version
of the informed consent form presented on a secure web page (i.e., communication between the
phone's browser and web page are encrypted). Women who agree to participate will acknowledge
consent by clicking a button at the bottom of the online consent form that reads "I
understand and CONSENT to participate." Women who choose not to participate after reading the
informed consent form will press a button that reads "I understand and choose NOT to
participate." These women will be thanked and all contact will cease.
Participants will be assigned to conditions using a permuted-blocks randomization scheme.
Blocks of size 4 and 6 will be used. Assignments within blocks will be random but balanced
among the two conditions and the order of the blocks (4 vs 6) also will be random. This
procedure will ensure that the number of participants randomized to each condition will be
equal, that any imbalance among the conditions at any point during the recruitment and
randomization will be modest, and that it will be very difficult to guess the assignment of
the next participant. After randomization has occurred, participants will complete the
baseline research survey via telephone.
The primary outcome will be a dichotomous composite HIV risk transmission score, calculated
by measuring whether a participant or the participant's partner consistently used at least
one effective method for reducing HIV transmission risk (i.e., adherence to biomedical [ART
or PrEP] and behavioral [condoms, serosorting] strategies) during each instance of anal sex
over the past month. Every anal sex act must be protected by one of these methods to receive
an overall composite score of 0. The individual behavioral components of the composite score
(i.e., percentage of condomless anal sex, serosorting, PrEP or ART adherence) will serve as
secondary measures. In addition, specific outcomes by HIV status will include HIV medical
care utilization and adherence, HIV testing, and PrEP knowledge, interest, and uptake.
Finally, further secondary measures will assess gender affirmation, well-being, social
support, and sexual communication.
Once the baseline research survey has been completed, participants will receive instructions
for accessing the assigned materials. Those in the experimental group will be instructed to
text the word "join" to the Shine study phone number. After joining, experimental group
participants will be enrolled in a mobile intervention that aims to reduce HIV health
disparities among African American TGW along the entire care continuum. Participants randomly
assigned to the control condition will be texted a link to a set of videos on healthy
HIV-related behaviors for transgender women. These videos cover a variety of topics,
including recommended testing frequencies, PrEP, and ART. All control participants will have
access to Shine at the end of the research study (i.e., approximately six months after
recruitment).
Six months after the baseline research survey, all participants will complete a follow-up
research survey assessing the same outcome measures in the baseline research survey.
Given a sample size of 215 and a predicted retention rate of 80%, the investigators
anticipate having complete data for at least 172 participants at the close of the study.
Because randomization carries the expectation of creating treatment groups equivalent with
respect to known and unknown prognostic factors, removing randomized participants from the
analysis runs the risk of tampering with this balance and introducing bias into the treatment
comparisons. As a result, an intention-to-treat analytic approach will be followed such that
all participants randomized into the study will be included in all analyses irrespective of
protocol violations post randomization. Multiple imputation is now widely regarded as an
effective method for replacing missing data, and the investigators will use this approach.
Binomial logistic regression will be the main analytic technique for the primary outcome
(composite HIV transmission risk score) and other non-continuous measures. For continuous
measures, hierarchical linear modeling (HLM) will be used. All models will control for any
demographic covariate (e.g., age) that varies at the .2 significance level due to
randomization failure at baseline.
To ensure this study will be fully powered, the investigators estimated power for the
binomial logistic regression analysis on the binary primary outcome measure (composite HIV
transmission risk score). To conduct this calculation, the investigators examined power from
Garofalo and colleagues' RCT of LifeSkills, a 6-session group-based, in person intervention
for young trans women of any HIV status. At the 12-month follow-up, TGW in the
empowerment-based HIV intervention showed a 39.8% greater reduction in condomless sex
compared to participants in a standard care control condition (risk ratio = .60). This effect
is described as "robust" by the authors but is typically interpreted as a small-medium effect
size (Cohen's d=.35). This study provides an adequate power comparison for two reasons.
First, this intervention (empowerment-based) and population (specifically tailored for TGW)
closely align with the proposed work. Second, this effect size is consistent with the average
effect size of SMS-based interventions on health behaviors (d = .33). As the effect size for
the binomial logistic regression is an odds ratio, the investigators translated the Cohen's d
of .35 to an odds ratio of 1.89. The G*Power 3.1 program was then used to determine that an
odds ratio of 1.89 and an α error probability of 0.05 requires a sample size of 172 to be
sufficiently powered at 1-β error probability = 0.95. Therefore, the 172 participants the
investigators expect to retain through the follow-up, given a sample size of 215 and a 20%
attrition rate, should be sufficient to detect significant differences in composite risk for
HIV transmission at follow-up.
