HIVNCT04491422
Same-Day PrEP Initiation and Sexual Health for Transgender Women
A study testing Integrated Next Steps Counseling with Real-Time Drug Level Feedback in people with HIV and PrEP, run by Makerere University at 1 site in Uganda.
Trial summary
Transgender women (trans women; assigned male sex at birth but identify as female) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Read more about this study
- Who is it for?
- Ages 14 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, PrEP, Transgender Women
- What is being tested?
- Integrated Next Steps Counseling with Real-Time Drug Level Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUganda
- Study dates
- 2 Nov 2021to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Report male sex assigned at birth but currently identify as female
- Age ≥18, or if 14-17 years, qualification as a mature or emancipated minor due to having a sexually transmitted infection or cater for own livelihood
- Report unprotected anal intercourse in the past 6 months
- Able and willing to provide written informed consent
- Possess a valid recruitment coupon
- HIV-uninfected based on negative HIV rapid tests at the enrollment visit
Who cannot join
- Currently enrolled in a biomedical HIV prevention study
- Any clinically significant or chronic medical condition that is considered progressive or in the opinion of the investigator would make the participant unsuitable for the study, including severe infections requiring treatment such as tuberculosis, alcohol or drug abuse, or mental illness which precludes provision of informed consent
- Not planning to remain in the geographic area for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Transgender women (trans women; assigned male sex at birth but identify as female) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Trans women have a 13 times greater risk of acquiring HIV than adults aged 15-49 years in the general population, and in Africa, trans women have nearly twice the HIV prevalence (25%) of men who have sex with men [MSM] (14%). Oral pre-exposure prophylaxis (PrEP) is an effective prevention tool that could change the trajectory of the HIV epidemic among the 25 million trans women globally, yet its use has been suboptimal in this vulnerable population. Same-day PrEP initiation is feasible and acceptable and improves retention in PrEP care in resource-rich settings. Same-day initiation of emtricitabine/tenofovir alafenamide (F/TAF), a new PrEP regimen, has not to our knowledge previously been evaluated as PrEP in African trans women. F/TAF is potentially more efficacious and safer than emtricitabine/tenofovir disoproxil fumarate (F/TDF) as shown in the recent DISCOVER trial. However, concerns about drug-drug interactions between feminizing hormonal therapy (FHT) and PrEP are a key potential adherence barrier for trans women. While PrEP drugs do not lower FHT levels, FHT decreases plasma TFV and (emtricitabine) FTC levels. Little is known about FHT use among African trans women taking F/TAF or how concerns about F/TAF-FHT interactions may influence PrEP adherence. Moreover, interventions to support PrEP adherence in this population are needed. Feedback about PrEP use has been shown to potentially improve PrEP adherence among MSM but has not been utilized among trans women. Key knowledge gaps include: 1) whether same-day PrEP can be successfully implemented for African trans women, 2) the impact of drug-level feedback on PrEP adherence, and 3) how use of FHT may influence PrEP adherence.
To address these questions, this protocol describes a randomized trial to evaluate the feasibility and acceptability of same day initiation of F/TAF PrEP, evaluate impact of drug-level feedback on PrEP adherence and characterize PrEP persistence, and in-depth interviews to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. This will be the first clinical trial, to our knowledge, to evaluate F/TAF as PrEP for HIV-negative trans women in sub-Saharan Africa.
Read the detailed description
The overall goal of this study is to evaluate the feasibility and acceptability of same-day F/TAF initiation and characterize F/TAF persistence among trans women taking PrEP. This research will be conducted at the Infectious Diseases Institute, Makerere University in Kampala, Uganda and consists of 3 complementary aims. In Aims 1 and 2, the investigators will assess the feasibility and acceptability of same-day F/TAF initiation and characterize PrEP persistence. In Aim 3, the investigators will use qualitative methods to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. Study subjects will be accrued using respondent driven sampling (RDS) and enrolled at the study clinic where F/TAF will be initiated same day. Participants will be randomized in a 1:1 ratio to either the intervention arm (quarterly integrated next steps counseling [iNSC] using point-of-care [POC] urine tenofovir [TFV] levels) or the control arm (standard adherence counseling without drug level feedback). In Aim 3, the investigators will use qualitative methods to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. The overall goal will be to assess whether POC urine testing and iNSC counseling increase PrEP uptake and persistence over 12 months. This study for trans women is guided by the cardinal ethical principles of justice, respect for persons and beneficence. The local trans community will be involved in study design and implementation.
Aim 1 : Evaluate the feasibility and acceptability of same-day F/TAF PrEP initiation among African trans women.
Approach: The investigators will recruit up to 200 trans women. All study participants who meet study eligibility criteria will be consented and enrolled at the study clinic. Randomization will occur through REDCap. Participants will start PrEP on the day of enrollment and receive F/TAF for 12 months. Free HIV and sexually transmitted infection (STI) testing and treatment will be provided to all participants.
Aim 2 : Characterize F/TAF persistence and test the impact of drug level feedback among African trans women taking PrEP.
Approach: Using a factorial design within the Aim 1 study, all F/TAF users will be randomized to real-time drug level feedback and adherence counseling using a POC urine TFV lateral-flow immunoassay versus standard counseling alone. Socio-behavioral surveys will assess potential factors influencing adherence, including gender dysphoria and FHT.
Aim 3 : Explore how self-care interventions for sexual health influence HIV/STI prevention choices among African trans women and their sexual partners.
Approach: To clarify how same-day PrEP initiation, FHT use and self-collection of samples (SCS) for STI testing may influence prevention choices, the investigators will conduct in-depth interviews with participants and their sexual partners to assess perceptions and experiences with same-day PrEP, real-time drug level feedback, use of FHT, SCS, and how self-care interventions could empower trans women to engage in prevention services.
Hypothesis: Same-day PrEP initiation will be a feasible and acceptable entryway into PrEP care among trans women.
- Conditions
- HIV, PrEP, Transgender Women, Sexually Transmitted Diseases, Bacterial
- Being tested
- Integrated Next Steps Counseling with Real-Time Drug Level Feedback
- Medical subject headings
- Sexually Transmitted Diseases, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Next Steps Counseling with Real-Time Drug Level FeedbackCombination product
Integrated next steps counseling with real-time drug level feedback using point-of-care urine tenofovir testing at quarterly visits
| Study group | Role | What they receive |
|---|---|---|
| Integrated Next Steps Counseling using poi | Active comparator | At quarterly visits, intervention arm participants will receive iNSC Support Level 1 to address PrEP adherence and sexual health needs. Those with urine TFV levels <1000 ng/mL will receive iNSC Support Level 2, in which participant responses to two 7-item questionnaires on PrEP adherence and sexual health will guide problem solving on improved dosing. Receives: Combination Product: Integrated Next Steps Counseling with Real-Time Drug Level Feedback |
| Standard adherence counseling | No intervention | Control arm participants will receive standard adherence counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of same-day initiation of F/TAF as PrEP as measured by participant engagement until the end of study
Proportion retained on PrEP at months 3, 6, 9 and 12
Measured: 12 months
Acceptability of peer-delivered combination HIV prevention as measured by the System Usability Scale
System Usability Scale scores range from 0 to 100; higher scores mean better acceptability
Measured: 12 months
Adoption of same-day PrEP initiation as measured by structured questionnaires
Proportion initiating same-day PrEP at enrollment
Measured: 12 months
Fidelity to iNSC assessed through audio-recorded drug level feedback counseling sessions
Proportion of research nurses successfully implementing iNSC
Measured: 12 months
PrEP persistence as measured by intracellular tenofovir diphosphate levels in dried blood spots at months 3, 6, 9, 12
Proportion with tenofovir diphosphate levels >900 fmol per punch
Measured: 12 months
Secondary outcomes (2)
Sexual risk behaviors assessed through structured questionnaires
Proportion reporting unprotected sex, sexual frequency
Measured: 12 months
STI incidence assessed through GeneXpert testing
Neisseria gonorrhoeae and Chlamydia trachomatis incidence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start2 Nov 2021
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either quarterly Integrated Next Steps Counseling (iNSC) using point-of-care (POC) urine tenofovir (TFV) levels \[intervention arm\] or standard adherence counseling without drug level feedback \[control arm\].
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Harvard Medical School (HMS and HSDM), University of Washington
- Responsible party
- Sponsor
- Investigators
- Andrew Mujugira, PhD, Principal investigator, Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491422
- Sponsor's protocol ID
- REC REF 0105-2020
- Status last verified
- Oct 2023
- First submitted
- 16 Jul 2020
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same-Day PrEP Initiation and Sexual Health for Transgender Women
- ClinicalTrials.gov ID
- NCT04491422
- Acronym / sponsor ID
- REC REF 0105-2020
- Conditions
- HIV, PrEP, Transgender Women, Sexually Transmitted Diseases, Bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Harvard Medical School (HMS and HSDM), University of Washington
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transgender women (trans women; assigned male sex at birth but identify as female) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Trans women have a 13 times greater risk of acquiring HIV than adults aged 15-49 years in the general population, and in Africa, trans women have nearly twice the HIV prevalence (25%) of men who have sex with men [MSM] (14%). Oral pre-exposure prophylaxis (PrEP) is an effective prevention tool that could change the trajectory of the HIV epidemic among the 25 million trans women globally, yet its use has been suboptimal in this vulnerable population. Same-day PrEP initiation is feasible and acceptable and improves retention in PrEP care in resource-rich settings. Same-day initiation of emtricitabine/tenofovir alafenamide (F/TAF), a new PrEP regimen, has not to our knowledge previously been evaluated as PrEP in African trans women. F/TAF is potentially more efficacious and safer than emtricitabine/tenofovir disoproxil fumarate (F/TDF) as shown in the recent DISCOVER trial. However, concerns about drug-drug interactions between feminizing hormonal therapy (FHT) and PrEP are a key potential adherence barrier for trans women. While PrEP drugs do not lower FHT levels, FHT decreases plasma TFV and (emtricitabine) FTC levels. Little is known about FHT use among African trans women taking F/TAF or how concerns about F/TAF-FHT interactions may influence PrEP adherence. Moreover, interventions to support PrEP adherence in this population are needed. Feedback about PrEP use has been shown to potentially improve PrEP adherence among MSM but has not been utilized among trans women. Key knowledge gaps include: 1) whether same-day PrEP can be successfully implemented for African trans women, 2) the impact of drug-level feedback on PrEP adherence, and 3) how use of FHT may influence PrEP adherence.
To address these questions, this protocol describes a randomized trial to evaluate the feasibility and acceptability of same day initiation of F/TAF PrEP, evaluate impact of drug-level feedback on PrEP adherence and characterize PrEP persistence, and in-depth interviews to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. This will be the first clinical trial, to our knowledge, to evaluate F/TAF as PrEP for HIV-negative trans women in sub-Saharan Africa.
Detailed description
The overall goal of this study is to evaluate the feasibility and acceptability of same-day F/TAF initiation and characterize F/TAF persistence among trans women taking PrEP. This research will be conducted at the Infectious Diseases Institute, Makerere University in Kampala, Uganda and consists of 3 complementary aims. In Aims 1 and 2, the investigators will assess the feasibility and acceptability of same-day F/TAF initiation and characterize PrEP persistence. In Aim 3, the investigators will use qualitative methods to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. Study subjects will be accrued using respondent driven sampling (RDS) and enrolled at the study clinic where F/TAF will be initiated same day. Participants will be randomized in a 1:1 ratio to either the intervention arm (quarterly integrated next steps counseling [iNSC] using point-of-care [POC] urine tenofovir [TFV] levels) or the control arm (standard adherence counseling without drug level feedback). In Aim 3, the investigators will use qualitative methods to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. The overall goal will be to assess whether POC urine testing and iNSC counseling increase PrEP uptake and persistence over 12 months. This study for trans women is guided by the cardinal ethical principles of justice, respect for persons and beneficence. The local trans community will be involved in study design and implementation.
Aim 1 : Evaluate the feasibility and acceptability of same-day F/TAF PrEP initiation among African trans women.
Approach: The investigators will recruit up to 200 trans women. All study participants who meet study eligibility criteria will be consented and enrolled at the study clinic. Randomization will occur through REDCap. Participants will start PrEP on the day of enrollment and receive F/TAF for 12 months. Free HIV and sexually transmitted infection (STI) testing and treatment will be provided to all participants.
Aim 2 : Characterize F/TAF persistence and test the impact of drug level feedback among African trans women taking PrEP.
Approach: Using a factorial design within the Aim 1 study, all F/TAF users will be randomized to real-time drug level feedback and adherence counseling using a POC urine TFV lateral-flow immunoassay versus standard counseling alone. Socio-behavioral surveys will assess potential factors influencing adherence, including gender dysphoria and FHT.
Aim 3 : Explore how self-care interventions for sexual health influence HIV/STI prevention choices among African trans women and their sexual partners.
Approach: To clarify how same-day PrEP initiation, FHT use and self-collection of samples (SCS) for STI testing may influence prevention choices, the investigators will conduct in-depth interviews with participants and their sexual partners to assess perceptions and experiences with same-day PrEP, real-time drug level feedback, use of FHT, SCS, and how self-care interventions could empower trans women to engage in prevention services.
Hypothesis: Same-day PrEP initiation will be a feasible and acceptable entryway into PrEP care among trans women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either quarterly Integrated Next Steps Counseling (iNSC) using point-of-care (POC) urine tenofovir (TFV) levels [intervention arm] or standard adherence counseling without drug level feedback [control arm].
| Arm | Type | Receives |
|---|---|---|
| Integrated Next Steps Counseling using poi | Active comparator | Combination Product: Integrated Next Steps Counseling with Real-Time Drug Level FeedbackAt quarterly visits, intervention arm participants will receive iNSC Support Level 1 to address PrEP adherence and sexual health needs. Those with urine TFV levels <1000 ng/mL will receive iNSC Support Level 2, in which participant responses to two 7-item questionnaires on PrEP adherence and sexual health will guide problem solving on improved dosing. |
| Standard adherence counseling | No intervention | –Control arm participants will receive standard adherence counseling. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Report male sex assigned at birth but currently identify as female
- Age ≥18, or if 14-17 years, qualification as a mature or emancipated minor due to having a sexually transmitted infection or cater for own livelihood
- Report unprotected anal intercourse in the past 6 months
- Able and willing to provide written informed consent
- Possess a valid recruitment coupon
Key exclusion criteria (3 listed)
- Currently enrolled in a biomedical HIV prevention study
- Any clinically significant or chronic medical condition that is considered progressive or in the opinion of the investigator would make the participant unsuitable for the study, including severe infections requiring treatment such as tuberculosis, alcohol or drug abuse, or mental illness which precludes provision of informed consent
- Not planning to remain in the geographic area for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Next Steps Counseling with Real-Time Drug Level FeedbackIntegrated next steps counseling with real-time drug level feedback using point-of-care urine tenofovir testing at quarterly visits | Combination product | Integrated Next Steps Counseling using poi |
Primary outcome
Feasibility of same-day initiation of F/TAF as PrEP as measured by participant engagement until the end of study
Time frame: 12 months
Proportion retained on PrEP at months 3, 6, 9 and 12
Acceptability of peer-delivered combination HIV prevention as measured by the System Usability Scale
Time frame: 12 months
System Usability Scale scores range from 0 to 100; higher scores mean better acceptability
Adoption of same-day PrEP initiation as measured by structured questionnaires
Time frame: 12 months
Proportion initiating same-day PrEP at enrollment
Fidelity to iNSC assessed through audio-recorded drug level feedback counseling sessions
Time frame: 12 months
Proportion of research nurses successfully implementing iNSC
PrEP persistence as measured by intracellular tenofovir diphosphate levels in dried blood spots at months 3, 6, 9, 12
Time frame: 12 months
Proportion with tenofovir diphosphate levels >900 fmol per punch
2 secondary outcomes
Sexual risk behaviors assessed through structured questionnaires
Time frame: 12 months
STI incidence assessed through GeneXpert testing
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Mujugira, PhD principal investigator
Infectious Diseases Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Next Steps Counseling with Real-Time Drug Level Feedback in people with HIV and PrEP, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of same-day initiation of F/TAF as PrEP as measured by participant engagement until the end of study (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.