Pre-Exposure Prophylaxis for Transgender Women in the US and South America

Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date.

Self-reported adherence to daily PrEP by study visit

Number of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits.

Participant retention at weeks 26, 52 and 78 by study arm. Retention defined as the number of participants who completed the visit divided by the number of participants who are expected or have completed the visit.

The average number of peer health navigator encounters.

Number of each type of peer health navigation encounter.

Percentage of participants who report desire for co-located services at the end of the study

The average number of days to first PrEP permanent discontinuation.

The median number of days to first PrEP permanent discontinuation.

Participants with different levels of TFV-DP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.

Participants with different levels FTC-TP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.

The proportion of TGW determined to be adherent at the Week 26 visit was compared by study arm. PrEP adherence was defined as having a detectable concentration of PrEP (Truvada or Descovy) in DBS sample.

PrEP persistent is defined as the proportion of study visits where a participant demonstrates high adherence to PrEP among those who initiated PrEP at the study clinic. High adherence at a visit is based on drug concentrations in dried blood spots (DBS):

Truvada (TDF/FTC): TFV-DP ≥ 900 fmol/punch Descovy (TAF/FTC): TFV-DP ≥ 950 fmol/punch PrEP persistent reflects sustained high PrEP adherence across multiple visits over time, rather than high PrEP adherence at a single point.

Comparison of PrEP uptake between study arms at the end of Week 26. PrEP uptake is defined as whether the participant initiated PrEP at the study clinic..

Describing condom use with HIV+ people, measured by assessments at enrollment and quarterly through Week 78.

Describing condom use with HIV unknown people, measured by assessments at enrollment and quarterly through Week 78.

Frequency of being high on drugs/drunk during sex, measured by assessments at enrollment and quarterly through Week 78.

Had sex for money/drugs/housing/food/other things, measured by assessments at enrollment and quarterly through Week 78.

To determine baseline prevalence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) by study arm

To obtain baseline laboratory data to evaluate the cohort's suitability for future PrEP intervention studies (e.g., prevalence of renal insufficiency, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, etc.). Logistic regression models will be used for estimating prevalence of baseline conditions.

Taken hormones for gender identity/transition

Currently taking hormones for gender identity/transition

Where do you currently get your hormones?

Ever had a substance (like silicone or other fillers) injected to fill out face or make figure look more womanly

Ever had breast augmentation/surgery

Ever had vaginoplasty/labiaplasty/SRS/GRS/GCS

The number of incident HIV infections at each time point by arm.

Note: The HIV infection reported at Week 26 occurred during an interim visit between Week 26 and Week 39.

To determine annual incidence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) and to examine changes in STI over time by study arm.

PrEP uptake is defined as whether the participant initiated PrEP at the study clinic during the study cycle.

The number of study visits at which participants were highly adherent to PrEP, among those who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS):

Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch

Arm-level results are presented as the total number of visits at which participants in each arm were highly adherent to PrEP, reported as the number and percentage of visits.

PrEP persistence is defined as the proportion of study visits at which a participant demonstrates high adherence to PrEP among participants who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS):

Truvada: TFV-DP ≥ 900 fmol/punch

Descovy: TFV-DP ≥ 950 fmol/punch

PrEP persistence reflects sustained high adherence across multiple visits over time per participant, rather than overall high adherence at all time points. For each participant, this proportion was converted to a percentage; arm-level results are presented as the mean of participant-level percentages in each arm in the outcome measure data table.

An overall composite flag (Yes/No) for interest in future HIV research was created at the end of study using participant responses collected at enrollment, weeks 26, 52, and 78. Those who showed interest in future HIV research (Yes) were reported in the outcome measure data table.