A Phase 2/3 interventional study of Immediate Intervention Arm and Deferred Intervention Arm in HIV Prevention, sponsored by HIV Prevention Trials Network. Completed at 5 sites in 2 countries. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by HIV Prevention Trials Network · Phase 2/3, Interventional, and Prevention
A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention co-located with gender-affirming transgender care (hormonal therapy and medical monitoring) and Peer Health Navigation (PHN) using Strengths-Based Case Management (SBCM) professional supervision.
Multi-site, open-label study with each participant randomized 1:1 to Immediate Intervention vs. 6-month Deferred Intervention Arms. Both arms will be provided PrEP and sexually transmitted infection (STI) screening and treatment. Participants in the Immediate Intervention Arm will receive co-located gender-affirming medical care and PHN using SBCM starting at the Enrollment Visit. Participants in the Deferred Intervention Arm will receive linkage to external gender-affirming medical care and case management services during the deferred period and will transition to the study intervention six months following the Enrollment Visit.
entered elsewhere
HIV Prevention Trials Network is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At risk for sexually acquiring HIV infection based on self-report of at least one of the following:
General good health, as evidenced by the following laboratory values:
Note: Otherwise eligible participants with laboratory results outside the above-mentioned values, with the exception of those with reactive HIV test, can be re-tested during the screening window. Participants with reactive HIV tests will not be able to rescreen.
Note: Participants who practice receptive vaginal sex cannot be provided Descovy® as it is not approved for this indication.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PrEP (pre-exposure prophylaxis) provision, STI screening and treatment, GAHT (gender-affirming hormonal therapy), peer-health management using strengths-based management. PrEP provision includes using one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil.
Drug: Immediate Intervention Arm
0-6 months PrEP (pre-exposure prophylaxis) provision and STI screening and treatment. From months 6-18, GAHT (gender-affirming hormonal therapy) and peer-health management using strengths-based management. PrEP provision includes one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily table of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil.
Drug: Deferred Intervention Arm
Truvada, Descovy in the United States; Truvada in Brazil
Also known as: Truvada, Descovy
Truvada, Descovy in the United States; Truvada in Brazil
Also known as: Truvada, Descovy
PrEP Uptake
Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date.
Time frame: 0-18 months
PrEP Adherence
Self-reported adherence to daily PrEP by study visit
Time frame: 0-18 months
Acceptability and Feasibility of Co-located Services
Number of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits.
Time frame: 0-18 months
Participant Retention at Weeks 26, 52 and 78
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.
Time frame: Weeks 26, 52, 78
Acceptability and Feasibility of Peer Health Navigation
The average number of peer health navigator encounters.
Time frame: 0-18 months
Acceptability and Feasibility of Peer Health Navigation
Number of each type of peer health navigation encounter.
Time frame: 0-18 months
Acceptability and Feasibility of Co-located Services
Percentage of participants who report desire for co-located services at the end of the study
Time frame: 0-18 months
PrEP Adherence
The average number of days to first PrEP permanent discontinuation.
Time frame: 0-18 months
PrEP Adherence
The median number of days to first PrEP permanent discontinuation.
Time frame: 0-18 months
PrEP Adherence
Participants with different levels of TFV-DP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.
Time frame: 0-18 months
PrEP Adherence
Participants with different levels FTC-TP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.
Time frame: 0-18 months
PrEP Adherence
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.
Time frame: Week 26
PrEP Persistent
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.
Time frame: 0-18 months
PrEP Uptake
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..
Time frame: Week 26
Examining Changes in Sexual Risk-taking Behavior
Describing condom use with HIV+ people, measured by assessments at enrollment and quarterly through Week 78.
Time frame: 0-18 months
Examining Changes in Sexual Risk-taking Behavior
Describing condom use with HIV unknown people, measured by assessments at enrollment and quarterly through Week 78.
Time frame: 0-18 months
Examining Changes in Sexual Risk-taking Behavior
Frequency of being high on drugs/drunk during sex, measured by assessments at enrollment and quarterly through Week 78.
Time frame: 0-18 months
Examining Changes in Sexual Risk-taking Behavior
Had sex for money/drugs/housing/food/other things, measured by assessments at enrollment and quarterly through Week 78.
Time frame: 0-18 months
Prevalence of STI Infection (GC, CT, Syphilis) at Baseline
To determine baseline prevalence of STIs (Neisseria gonorrhoeae \[GC\], Chlamydia trachomatis \[CT\], and Treponema pallidum (syphilis)) by study arm
Time frame: 0 months
Estimate Prevalence of Baseline Laboratory Values.
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.
Time frame: 0 months
Gender-Affirming Hormone Therapy by Visit
Taken hormones for gender identity/transition
Time frame: 0-18 months
Gender-Affirming Hormone Therapy by Visit
Currently taking hormones for gender identity/transition
Time frame: 0-18 months
Gender-Affirming Hormone Therapy by Visit
Where do you currently get your hormones?
Time frame: 0-18 months
Gender-Affirming Hormone Therapy by Visit
Ever had a substance (like silicone or other fillers) injected to fill out face or make figure look more womanly
Time frame: 0-18 months
Gender-Affirming Hormone Therapy by Visit
Ever had breast augmentation/surgery
Time frame: 0-18 months
Gender-Affirming Hormone Therapy by Visit
Ever had vaginoplasty/labiaplasty/SRS/GRS/GCS
Time frame: 0-18 months
Annual Incidence of HIV Infections
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.
Time frame: 0-18 months
Incidence of STI Infection (GC, CT, Syphilis)
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.
Time frame: 0-18 months
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake
PrEP uptake is defined as whether the participant initiated PrEP at the study clinic during the study cycle.
Time frame: 0-18 months
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits.
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.
Time frame: 0-18 months
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence
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.
Time frame: 0-18 months
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research
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.
Time frame: 0-18 months
| Milestone | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Started | 149 | 155 |
| Week 13 follow-up | 133 | 139 |
| Week 26 follow-up | 125 | 136 |
| Week 39 follow-up | 118 | 128 |
| Week 52 follow-up | 116 | 123 |
| Week 65 follow-up | 114 | 126 |
| Completed | 126 | 128 |
| Not completed | 23 | 27 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Participant unwilling or unable to comply with required study procedures | 1 | 1 |
| Withdrew: Lost to follow-up | 6 | 8 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Withdrew: One or more reactive hiv test results or acute hiv infection suspected | 2 | 1 |
| Withdrew: Participant refused further participation | 2 | 7 |
| Withdrew: Participant unable to adhere to visit schedule | 3 | 4 |
| Withdrew: Other reasons | 3 | 4 |
Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date.
| days | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| PrEP Uptake | 16.2 ± 66.7 | 11.4 ± 4.3 |
Self-reported adherence to daily PrEP by study visit
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment — < 2 doses per week | 2 | 1 |
| Enrollment — 2-3 doses per week | 2 | 3 |
| Enrollment — 4-6 doses per week | 6 | 4 |
| Enrollment — 7 doses per week | 19 | 20 |
| Enrollment — Missing | 118 | 125 |
| Week 13 — < 2 doses per week | 3 | 8 |
| Week 13 — 2-3 doses per week | 2 | 3 |
| Week 13 — 4-6 doses per week | 19 | 27 |
| Week 13 — 7 doses per week | 79 | 75 |
| Week 13 — Missing | 30 | 26 |
| Week 26 — < 2 doses per week | 7 | 7 |
| Week 26 — 2-3 doses per week | 7 | 2 |
| Week 26 — 4-6 doses per week | 12 | 21 |
| Week 26 — 7 doses per week | 76 | 72 |
| Week 26 — Missing | 22 | 29 |
| Week 39 — < 2 doses per week | 4 | 4 |
| Week 39 — 2-3 doses per week | 3 | 5 |
| Week 39 — 4-6 doses per week | 16 | 23 |
| Week 39 — 7 doses per week | 61 | 71 |
| Week 39 — Missing | 30 | 25 |
| Week 52 — < 2 doses per week | 4 | 5 |
| Week 52 — 2-3 doses per week | 3 | 5 |
| Week 52 — 4-6 doses per week | 18 | 16 |
| Week 52 — 7 doses per week | 53 | 63 |
| Week 52 — Missing | 37 | 31 |
| Week 65 — < 2 doses per week | 2 | 5 |
| Week 65 — 2-3 doses per week | 1 | 5 |
| Week 65 — 4-6 doses per week | 16 | 21 |
| Week 65 — 7 doses per week | 57 | 61 |
| Week 65 — Missing | 33 | 30 |
| Week 78 — < 2 doses per week | 3 | 9 |
| Week 78 — 2-3 doses per week | 7 | 7 |
| Week 78 — 4-6 doses per week | 17 | 16 |
| Week 78 — 7 doses per week | 51 | 61 |
| Week 78 — Missing | 47 | 36 |
Number of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment | 68 | 0 |
| Week 13 | 106 | 0 |
| Week 26 | 109 | 66 |
| Week 39 | 113 | 90 |
| Week 52 | 114 | 93 |
| Week 65 | 115 | 93 |
| Week 78 | 116 | 93 |
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.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Week 26 | 125 | 135 |
| Week 52 | 115 | 123 |
| Week 78 | 126 | 128 |
The average number of peer health navigator encounters.
| encounters | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Acceptability and Feasibility of Peer Health Navigation | 5.7 ± 1.6 | 5.5 ± 1.2 |
Number of each type of peer health navigation encounter.
| Encounters | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| In-person | 519 | 427 |
| 0 | 0 | |
| Text | 16 | 7 |
| Phone | 258 | 256 |
| Video encounter | 46 | 47 |
Percentage of participants who report desire for co-located services at the end of the study
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Acceptability and Feasibility of Co-located Services | 106 | 107 |
The average number of days to first PrEP permanent discontinuation.
| days | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| PrEP Adherence | 364.1 ± 185.2 | 361.1 ± 255.2 |
The median number of days to first PrEP permanent discontinuation.
| days | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| PrEP Adherence | 373 (245 to 499) | 409 (141 to 533) |
Participants with different levels of TFV-DP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment — Unquantifiable | 80 | 83 |
| Enrollment — Less than 2 doses per week | 10 | 15 |
| Enrollment — 2-3 doses per week | 5 | 3 |
| Enrollment — 4-6 doses per week | 5 | 12 |
| Enrollment — 7 doses per week | 5 | 4 |
| Week 13 — Unquantifiable | 19 | 10 |
| Week 13 — Less than 2 doses per week | 23 | 25 |
| Week 13 — 2-3 doses per week | 6 | 10 |
| Week 13 — 4-6 doses per week | 28 | 27 |
| Week 13 — 7 doses per week | 35 | 43 |
| Week 26 — Unquantifiable | 21 | 20 |
| Week 26 — Less than 2 doses per week | 23 | 28 |
| Week 26 — 2-3 doses per week | 8 | 12 |
| Week 26 — 4-6 doses per week | 32 | 26 |
| Week 26 — 7 doses per week | 24 | 34 |
| Week 39 — Unquantifiable | 31 | 23 |
| Week 39 — Less than 2 doses per week | 19 | 19 |
| Week 39 — 2-3 doses per week | 6 | 9 |
| Week 39 — 4-6 doses per week | 22 | 27 |
| Week 39 — 7 doses per week | 22 | 34 |
| Week 52 — Unquantifiable | 29 | 22 |
| Week 52 — Less than 2 doses per week | 18 | 17 |
| Week 52 — 2-3 doses per week | 14 | 8 |
| Week 52 — 4-6 doses per week | 19 | 32 |
| Week 52 — 7 doses per week | 20 | 31 |
| Week 65 — Unquantifiable | 27 | 21 |
| Week 65 — Less than 2 doses per week | 19 | 26 |
| Week 65 — 2-3 doses per week | 12 | 9 |
| Week 65 — 4-6 doses per week | 17 | 22 |
| Week 65 — 7 doses per week | 23 | 35 |
| Week 78 — Unquantifiable | 39 | 32 |
| Week 78 — Less than 2 doses per week | 22 | 20 |
| Week 78 — 2-3 doses per week | 10 | 12 |
| Week 78 — 4-6 doses per week | 16 | 23 |
| Week 78 — 7 doses per week | 23 | 27 |
Participants with different levels FTC-TP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment | 15 | 20 |
| Week 13 | 73 | 87 |
| Week 26 | 67 | 74 |
| Week 39 | 51 | 75 |
| Week 52 | 52 | 75 |
| Week 65 | 55 | 70 |
| Week 78 | 51 | 59 |
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.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| PrEP Adherence | 87 | 100 |
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.
| percent of visits | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| PrEP Persistent | 41.7 ± 40.9 | 50.5 ± 43.2 |
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..
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| PrEP Uptake | 127 | 135 |
Describing condom use with HIV+ people, measured by assessments at enrollment and quarterly through Week 78.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment — Missing | 0 | 1 |
| Enrollment — No sex | 9 | 12 |
| Enrollment — Oral sex only | 10 | 7 |
| Enrollment — I did not have sex with anyone whom I knew was HIV+ | 101 | 88 |
| Enrollment — None of the time | 11 | 19 |
| Enrollment — Less than half the time | 3 | 7 |
| Enrollment — About half the time | 2 | 4 |
| Enrollment — More than half the time | 5 | 4 |
| Enrollment — All of the time | 6 | 11 |
| Week 13 — Missing | 0 | 1 |
| Week 13 — No sex | 11 | 16 |
| Week 13 — Oral sex only | 10 | 8 |
| Week 13 — I did not have sex with anyone whom I knew was HIV+ | 81 | 87 |
| Week 13 — None of the time | 7 | 8 |
| Week 13 — Less than half the time | 6 | 3 |
| Week 13 — About half the time | 1 | 3 |
| Week 13 — More than half the time | 9 | 1 |
| Week 13 — All of the time | 8 | 12 |
| Week 26 — Missing | 0 | 1 |
| Week 26 — No sex | 18 | 14 |
| Week 26 — Oral sex only | 17 | 9 |
| Week 26 — I did not have sex with anyone whom I knew was HIV+ | 69 | 80 |
| Week 26 — None of the time | 6 | 8 |
| Week 26 — Less than half the time | 3 | 6 |
| Week 26 — About half the time | 3 | 1 |
| Week 26 — More than half the time | 1 | 3 |
| Week 26 — All of the time | 7 | 9 |
| Week 39 — Missing | 0 | 2 |
| Week 39 — No sex | 13 | 13 |
| Week 39 — Oral sex only | 13 | 9 |
| Week 39 — I did not have sex with anyone whom I knew was HIV+ | 68 | 75 |
| Week 39 — None of the time | 6 | 12 |
| Week 39 — Less than half the time | 3 | 3 |
| Week 39 — About half the time | 2 | 3 |
| Week 39 — More than half the time | 4 | 3 |
| Week 39 — All of the time | 5 | 8 |
| Week 52 — Missing | 4 | 6 |
| Week 52 — No sex | 18 | 12 |
| Week 52 — Oral sex only | 2 | 9 |
| Week 52 — I did not have sex with anyone whom I knew was HIV+ | 65 | 67 |
| Week 52 — None of the time | 7 | 12 |
| Week 52 — Less than half the time | 4 | 5 |
| Week 52 — About half the time | 1 | 2 |
| Week 52 — More than half the time | 5 | 1 |
| Week 52 — All of the time | 9 | 6 |
| Week 65 — Missing | 4 | 7 |
| Week 65 — No sex | 16 | 18 |
| Week 65 — Oral sex only | 6 | 2 |
| Week 65 — I did not have sex with anyone whom I knew was HIV+ | 62 | 70 |
| Week 65 — None of the time | 5 | 9 |
| Week 65 — Less than half the time | 4 | 3 |
| Week 65 — About half the time | 2 | 1 |
| Week 65 — More than half the time | 3 | 0 |
| Week 65 — All of the time | 7 | 12 |
| Week 78 — Missing | 9 | 4 |
| Week 78 — No sex | 23 | 20 |
| Week 78 — Oral sex only | 2 | 0 |
| Week 78 — I did not have sex with anyone whom I knew was HIV+ | 70 | 79 |
| Week 78 — None of the time | 4 | 12 |
| Week 78 — Less than half the time | 3 | 3 |
| Week 78 — About half the time | 6 | 1 |
| Week 78 — More than half the time | 1 | 2 |
| Week 78 — All of the time | 7 | 8 |
Describing condom use with HIV unknown people, measured by assessments at enrollment and quarterly through Week 78.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment — Missing | 0 | 1 |
| Enrollment — No sex | 9 | 12 |
| Enrollment — Oral sex only | 10 | 7 |
| Enrollment — No sex with anyone whose HIV status was unknown | 30 | 37 |
| Enrollment — None of the time | 20 | 17 |
| Enrollment — Less than half the time | 20 | 19 |
| Enrollment — About half the time | 13 | 9 |
| Enrollment — More than half of the time | 18 | 22 |
| Enrollment — All of the time | 27 | 29 |
| Week 13 — Missing | 0 | 1 |
| Week 13 — No sex | 11 | 16 |
| Week 13 — Oral sex only | 10 | 8 |
| Week 13 — No sex with anyone whose HIV status was unknown | 34 | 34 |
| Week 13 — None of the time | 24 | 19 |
| Week 13 — Less than half the time | 9 | 15 |
| Week 13 — About half the time | 10 | 5 |
| Week 13 — More than half of the time | 16 | 19 |
| Week 13 — All of the time | 19 | 22 |
| Week 26 — Missing | 0 | 1 |
| Week 26 — No sex | 18 | 14 |
| Week 26 — Oral sex only | 17 | 9 |
| Week 26 — No sex with anyone whose HIV status was unknown | 28 | 40 |
| Week 26 — None of the time | 14 | 21 |
| Week 26 — Less than half the time | 11 | 13 |
| Week 26 — About half the time | 7 | 6 |
| Week 26 — More than half of the time | 13 | 10 |
| Week 26 — All of the time | 16 | 17 |
| Week 39 — Missing | 0 | 2 |
| Week 39 — No sex | 13 | 13 |
| Week 39 — Oral sex only | 13 | 9 |
| Week 39 — No sex with anyone whose HIV status was unknown | 37 | 50 |
| Week 39 — None of the time | 13 | 10 |
| Week 39 — Less than half the time | 10 | 10 |
| Week 39 — About half the time | 6 | 3 |
| Week 39 — More than half of the time | 9 | 10 |
| Week 39 — All of the time | 13 | 21 |
| Week 52 — Missing | 4 | 6 |
| Week 52 — No sex | 18 | 12 |
| Week 52 — Oral sex only | 2 | 9 |
| Week 52 — No sex with anyone whose HIV status was unknown | 40 | 53 |
| Week 52 — None of the time | 11 | 9 |
| Week 52 — Less than half the time | 8 | 6 |
| Week 52 — About half the time | 5 | 3 |
| Week 52 — More than half of the time | 13 | 4 |
| Week 52 — All of the time | 14 | 18 |
| Week 65 — Missing | 4 | 7 |
| Week 65 — No sex | 16 | 18 |
| Week 65 — Oral sex only | 6 | 2 |
| Week 65 — No sex with anyone whose HIV status was unknown | 42 | 46 |
| Week 65 — None of the time | 16 | 15 |
| Week 65 — Less than half the time | 6 | 3 |
| Week 65 — About half the time | 2 | 6 |
| Week 65 — More than half of the time | 7 | 9 |
| Week 65 — All of the time | 10 | 16 |
| Week 78 — Missing | 9 | 4 |
| Week 78 — No sex | 23 | 20 |
| Week 78 — Oral sex only | 2 | 0 |
| Week 78 — No sex with anyone whose HIV status was unknown | 44 | 53 |
| Week 78 — None of the time | 15 | 15 |
| Week 78 — Less than half the time | 11 | 5 |
| Week 78 — About half the time | 2 | 7 |
| Week 78 — More than half of the time | 9 | 8 |
| Week 78 — All of the time | 10 | 17 |
Frequency of being high on drugs/drunk during sex, measured by assessments at enrollment and quarterly through Week 78.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment — Missing | 0 | 1 |
| Enrollment — No sex | 9 | 12 |
| Enrollment — Oral sex only | 10 | 7 |
| Enrollment — None of the time | 68 | 52 |
| Enrollment — Less than half the time | 34 | 40 |
| Enrollment — About half the time | 6 | 13 |
| Enrollment — More than half of the time | 12 | 15 |
| Enrollment — All of the time | 7 | 10 |
| Enrollment — Prefer not to answer | 1 | 3 |
| Week 13 — Missing | 0 | 1 |
| Week 13 — No sex | 11 | 16 |
| Week 13 — Oral sex only | 10 | 8 |
| Week 13 — None of the time | 72 | 53 |
| Week 13 — Less than half the time | 19 | 27 |
| Week 13 — About half the time | 9 | 16 |
| Week 13 — More than half of the time | 4 | 12 |
| Week 13 — All of the time | 7 | 3 |
| Week 13 — Prefer not to answer | 1 | 3 |
| Week 26 — Missing | 0 | 1 |
| Week 26 — No sex | 18 | 14 |
| Week 26 — Oral sex only | 17 | 9 |
| Week 26 — None of the time | 57 | 54 |
| Week 26 — Less than half the time | 21 | 33 |
| Week 26 — About half the time | 2 | 8 |
| Week 26 — More than half of the time | 2 | 6 |
| Week 26 — All of the time | 5 | 6 |
| Week 26 — Prefer not to answer | 2 | 0 |
| Week 39 — Missing | 0 | 2 |
| Week 39 — No sex | 13 | 13 |
| Week 39 — Oral sex only | 13 | 9 |
| Week 39 — None of the time | 51 | 51 |
| Week 39 — Less than half the time | 18 | 28 |
| Week 39 — About half the time | 8 | 11 |
| Week 39 — More than half of the time | 5 | 7 |
| Week 39 — All of the time | 3 | 6 |
| Week 39 — Prefer not to answer | 3 | 1 |
| Week 52 — Missing | 4 | 6 |
| Week 52 — No sex | 18 | 12 |
| Week 52 — Oral sex only | 2 | 9 |
| Week 52 — None of the time | 54 | 47 |
| Week 52 — Less than half the time | 21 | 25 |
| Week 52 — About half the time | 6 | 8 |
| Week 52 — More than half of the time | 3 | 6 |
| Week 52 — All of the time | 4 | 6 |
| Week 52 — Prefer not to answer | 3 | 1 |
| Week 65 — Missing | 4 | 7 |
| Week 65 — No sex | 16 | 18 |
| Week 65 — Oral sex only | 6 | 2 |
| Week 65 — None of the time | 58 | 51 |
| Week 65 — Less than half the time | 15 | 22 |
| Week 65 — About half the time | 5 | 11 |
| Week 65 — More than half of the time | 2 | 3 |
| Week 65 — All of the time | 2 | 4 |
| Week 65 — Prefer not to answer | 1 | 4 |
| Week 78 — Missing | 9 | 4 |
| Week 78 — No sex | 23 | 20 |
| Week 78 — Oral sex only | 2 | 0 |
| Week 78 — None of the time | 57 | 55 |
| Week 78 — Less than half the time | 18 | 29 |
| Week 78 — About half the time | 5 | 11 |
| Week 78 — More than half of the time | 6 | 5 |
| Week 78 — All of the time | 4 | 4 |
| Week 78 — Prefer not to answer | 1 | 1 |
Had sex for money/drugs/housing/food/other things, measured by assessments at enrollment and quarterly through Week 78.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment — Missing | 147 | 153 |
| Enrollment — No | 0 | 0 |
| Enrollment — Yes | 0 | 0 |
| Enrollment — Prefer not to answer | 0 | 0 |
| Week 13 — Missing | 0 | 1 |
| Week 13 — No | 90 | 101 |
| Week 13 — Yes | 40 | 32 |
| Week 13 — Prefer not to answer | 3 | 5 |
| Week 26 — Missing | 0 | 1 |
| Week 26 — No | 85 | 101 |
| Week 26 — Yes | 36 | 24 |
| Week 26 — Prefer not to answer | 3 | 5 |
| Week 39 — Missing | 0 | 0 |
| Week 39 — No | 83 | 104 |
| Week 39 — Yes | 29 | 21 |
| Week 39 — Prefer not to answer | 2 | 3 |
| Week 52 — Missing | 2 | 0 |
| Week 52 — No | 75 | 92 |
| Week 52 — Yes | 37 | 23 |
| Week 52 — Prefer not to answer | 1 | 5 |
| Week 65 — Missing | 0 | 0 |
| Week 65 — No | 77 | 99 |
| Week 65 — Yes | 29 | 21 |
| Week 65 — Prefer not to answer | 3 | 2 |
| Week 78 — Missing | 0 | 0 |
| Week 78 — No | 90 | 107 |
| Week 78 — Yes | 32 | 19 |
| Week 78 — Prefer not to answer | 3 | 3 |
To determine baseline prevalence of STIs (Neisseria gonorrhoeae \[GC\], Chlamydia trachomatis \[CT\], and Treponema pallidum (syphilis)) by study arm
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Gonorrhea | 15 | 15 |
| Chlamydia Trachomatis | 15 | 15 |
| Syphilis (Positive/Reactive) | 38 | 32 |
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.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Hepatitis B Infection | 0 | 1 |
| Hepatitis C Infection | 2 | 3 |
| Renal Insufficiency | 0 | 0 |
Taken hormones for gender identity/transition
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment | 96 | 101 |
| Week 13 | 91 | 96 |
| Week 26 | 93 | 93 |
| Week 39 | 85 | 96 |
| Week 52 | 86 | 93 |
| Week 65 | 82 | 90 |
| Week 78 | 93 | 96 |
Currently taking hormones for gender identity/transition
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment | 83 | 90 |
| Week 13 | 88 | 92 |
| Week 26 | 89 | 91 |
| Week 39 | 84 | 90 |
| Week 52 | 85 | 88 |
| Week 65 | 79 | 88 |
| Week 78 | 90 | 91 |
Where do you currently get your hormones?
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment — Missing | 0 | 0 |
| Enrollment — Only from medical providers | 47 | 50 |
| Enrollment — Medical providers and from friends, online, or other sources | 14 | 11 |
| Enrollment — Only from friends, online, or other non-licensed sources | 16 | 21 |
| Enrollment — Some other source | 6 | 8 |
| Week 13 — Missing | 0 | 0 |
| Week 13 — Only from medical providers | 70 | 72 |
| Week 13 — Medical providers and from friends, online, or other sources | 11 | 13 |
| Week 13 — Only from friends, online, or other non-licensed sources | 1 | 3 |
| Week 13 — Some other source | 6 | 4 |
| Week 26 — Missing | 0 | 0 |
| Week 26 — Only from medical providers | 68 | 80 |
| Week 26 — Medical providers and from friends, online, or other sources | 13 | 7 |
| Week 26 — Only from friends, online, or other non-licensed sources | 1 | 4 |
| Week 26 — Some other source | 7 | 0 |
| Week 39 — Missing | 0 | 0 |
| Week 39 — Only from medical providers | 65 | 78 |
| Week 39 — Medical providers and from friends, online, or other sources | 14 | 9 |
| Week 39 — Only from friends, online, or other non-licensed sources | 3 | 0 |
| Week 39 — Some other source | 2 | 3 |
| Week 52 — Missing | 0 | 0 |
| Week 52 — Only from medical providers | 69 | 74 |
| Week 52 — Medical providers and from friends, online, or other sources | 10 | 13 |
| Week 52 — Only from friends, online, or other non-licensed sources | 4 | 1 |
| Week 52 — Some other source | 2 | 0 |
| Week 65 — Missing | 0 | 0 |
| Week 65 — Only from medical providers | 59 | 70 |
| Week 65 — Medical providers and from friends, online, or other sources | 17 | 17 |
| Week 65 — Only from friends, online, or other non-licensed sources | 2 | 1 |
| Week 65 — Some other source | 1 | 0 |
| Week 78 — Missing | 0 | 0 |
| Week 78 — Only from medical providers | 68 | 71 |
| Week 78 — Medical providers and from friends, online, or other sources | 17 | 18 |
| Week 78 — Only from friends, online, or other non-licensed sources | 5 | 2 |
| Week 78 — Some other source | 0 | 0 |
Ever had a substance (like silicone or other fillers) injected to fill out face or make figure look more womanly
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment | 27 | 29 |
| Week 13 | 2 | 5 |
| Week 26 | 5 | 4 |
| Week 39 | 5 | 3 |
| Week 52 | 6 | 7 |
| Week 65 | 3 | 3 |
| Week 78 | 4 | 5 |
Ever had breast augmentation/surgery
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment | 36 | 25 |
| Week 13 | 3 | 1 |
| Week 26 | 5 | 1 |
| Week 39 | 3 | 1 |
| Week 52 | 5 | 0 |
| Week 65 | 4 | 0 |
| Week 78 | 1 | 1 |
Ever had vaginoplasty/labiaplasty/SRS/GRS/GCS
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment | 7 | 7 |
| Week 13 | 1 | 0 |
| Week 26 | 1 | 0 |
| Week 39 | 1 | 1 |
| Week 52 | 1 | 0 |
| Week 65 | 1 | 0 |
| Week 78 | 2 | 1 |
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.
| participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Enrollment | 0 | 0 |
| Week 13 | 0 | 0 |
| Week 26 | 1 | 0 |
| Week 39 | 2 | 1 |
| Week 52 | 0 | 0 |
| Week 65 | 0 | 0 |
| Week 78 | 2 | 0 |
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.
| participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Number of STI infections (first incidence) | 51 | 51 |
| Week 13 | 8 | 21 |
| Week 26 | 17 | 10 |
| Week 39 | 4 | 8 |
| Week 52 | 7 | 1 |
| Week 65 | 7 | 6 |
| Week 78 | 8 | 5 |
PrEP uptake is defined as whether the participant initiated PrEP at the study clinic during the study cycle.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake | 131 | 137 |
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.
| Visits | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits. | 291 | 377 |
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.
| Percentage of Visits | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence | 41.7 ± 40.9 | 50.5 ± 43.2 |
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.
| Participants | Immediate Intervention Arm | Deferred Intervention Arm |
|---|---|---|
| Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research | 149 | 153 |
Collected over From enrollment until end of follow-up (0-18 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Intervention Arm | 2/149 (1.3%) | 13/149 (8.7%) | 25/149 (16.8%) |
| Deferred Intervention Arm (0-6 Months) | 0/155 (0%) | 3/155 (1.9%) | 12/155 (7.7%) |
| Deferred Intervention Arm (6-18 Months) | 0/155 (0%) | 3/155 (1.9%) | 18/155 (11.6%) |
| Event | Immediate Intervention Arm | Deferred Intervention Arm (0-6 Months) | Deferred Intervention Arm (6-18 Months) |
|---|---|---|---|
| Atrial fibrillationCardiac disorders | 1/149 | 0/155 | 0/155 |
| Acute abdomenGastrointestinal disorders | 1/149 | 0/155 | 0/155 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/149 | 0/155 | 0/155 |
| DeathGeneral disorders | 1/149 | 0/155 | 0/155 |
| Multiple organ dysfunction syndromeGeneral disorders | 1/149 | 0/155 | 0/155 |
| Hepatitis acuteHepatobiliary disorders | 1/149 | 0/155 | 0/155 |
| HepatotoxicityHepatobiliary disorders | 1/149 | 0/155 | 0/155 |
| DiverticulitisInfections and infestations | 1/149 | 0/155 | 0/155 |
| Nosocomial infectionInfections and infestations | 1/149 | 0/155 | 0/155 |
| Septic shockInfections and infestations | 1/149 | 0/155 | 0/155 |
| Event | Immediate Intervention Arm | Deferred Intervention Arm (0-6 Months) | Deferred Intervention Arm (6-18 Months) |
|---|---|---|---|
| Creatinine renal clearance decreasedInvestigations | 13/149 | 5/155 | 13/155 |
| Blood creatinine increasedInvestigations | 5/149 | 3/155 | 5/155 |
| Suicidal ideationPsychiatric disorders | 2/149 | 0/155 | 0/155 |
| NauseaGastrointestinal disorders | 1/149 | 2/155 | 0/155 |
| Blood pressure increasedInvestigations | 0/149 | 0/155 | 2/155 |
| LymphopeniaBlood and lymphatic system disorders | 1/149 | 0/155 | 0/155 |
| Abdominal discomfortGastrointestinal disorders | 1/149 | 0/155 | 0/155 |
| Blood bilirubin increasedInvestigations | 1/149 | 0/155 | 0/155 |
| Blood cholesterol increasedInvestigations | 1/149 | 1/155 | 0/155 |
| Haemoglobin decreasedInvestigations | 1/149 | 0/155 | 1/155 |
The analysis population is the same as the assignment in Participant Flow.
| Age, Continuous(years) | Immediate Intervention Arm | Deferred Intervention Arm | Total |
|---|---|---|---|
| Mean | 30.3 ± 8.8 | 30.9 ± 8.8 | 30.6 ± 8.8 |
| Age, Customized(Participants) | Immediate Intervention Arm | Deferred Intervention Arm | Total |
|---|---|---|---|
| 25 and below | 57 | 47 | 104 |
| 26 and above | 92 | 108 | 200 |
| Sex/Gender, Customized(Participants) | Immediate Intervention Arm | Deferred Intervention Arm | Total |
|---|---|---|---|
| Gender — Missing | 0 | 1 | 1 |
| Gender — Female | 28 | 20 | 48 |
| Gender — Transgender Female/Transgender Woman | 65 | 76 | 141 |
| Gender — Gender nonbinary/Genderfluid/Gender Nonconforming | 3 | 9 | 12 |
| Gender — Another gender identity | 4 | 5 | 9 |
| Gender — Prefer not to answer | 0 | 0 | 0 |
| Gender — Multiple gender identities selected | 49 | 44 | 93 |
| Sex: Female, Male(Participants) | Immediate Intervention Arm | Deferred Intervention Arm | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 149 | 155 | 304 |
| Ethnicity (NIH/OMB)(Participants) | Immediate Intervention Arm | Deferred Intervention Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 82 | 81 | 163 |
| Not Hispanic or Latino | 62 | 72 | 134 |
| Unknown or Not Reported | 5 | 2 | 7 |
| Race (NIH/OMB)(Participants) | Immediate Intervention Arm | Deferred Intervention Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 4 | 6 |
| Asian | 2 | 7 | 9 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 46 | 50 | 96 |
| White | 53 | 54 | 107 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 45 | 40 | 85 |
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