Pre-Exposure ProphylaxisPhase 4NCT04664998
Alignment of PrEP Use With HIV Risk in Young Women and Men
A Phase 4 study testing Daily oral PrEP in people with Pre-Exposure Prophylaxis and Sexually Transmitted Diseases, Bacterial, run by University of Washington at 1 site in Uganda.
Trial summary
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial, HIV Infections
- What is being tested?
- Daily oral PrEP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUganda
- Study dates
- 1 May 2018to 10 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men ages ≥18
- Has a female sexual partner enrolled in the Kampala Women's Bone Study
- Willing and able to provide informed consent
- Participating in the Kampala Women's Bone Study
- Willing to talk with male sex partners about the new study for men and refer men for study recruitment
Who cannot join
- Has any other condition that would preclude the ability to provide informed consent, make study participation unsafe, complicate the interpretation of study findings or otherwise interfere with achievement of the study objectives, in the investigator's discretion.
- Eligibility for women:
- Has concerns about potential social harm stemming from anticipated conversations with male sex partners about the new study for men such that study staff would discourage the women from participation
- Investigator discretion
Trial locations and contacts
1 site in 1 country.
About this study
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs. In sub-Saharan Africa, young women are a priority population for HIV prevention and targeted to initiate PrEP, given their high HIV incidence rates and promising success from a strategy that can be used without the engagement of male partners. A key question in the field is whether young women using PrEP have ongoing HIV risk and adhere to PrEP sufficiently to have protection from HIV when they have condomless sex with HIV-infected partners. The only true way to know whether a heterosexual woman is sexually exposed to HIV or has a partner with high HIV risk is to test for HIV and STIs in her male partner(s) and quantify HIV viral levels, if any are detected. Yet engaging men in clinic-based HIV testing is challenging. More recent efforts have focused on using HIV self-testing kits to respond to demands on men's time and reluctance to seeking preventive healthcare. The availability of PrEP also provides a new incentive for men to test.
By leveraging an ongoing study of bone health with concurrent use of PrEP and injectable DMPA (often known as Depo Provera® or depot medroxyprogesterone acetate), we have opportunity to engage a new cohort of young men and objectively measure HIV and common STIs in these young men and link the results to women's use of PrEP. The primary objective of this study is to determine whether young women's adherence to PrEP aligns with the HIV status and risk of their male partners. To address its primary objectives, this study will leverage: 1) an ongoing study among young women and 2) a novel cohort of young men who are current sexual partners of the young women in the ongoing study to objectively measure PrEP use, HIV, and HIV factors related to HIV risk. This study will provide a framework for understanding how and when young women and men decide to take PrEP, estimate the proportion of women that are benefitting from HIV protection when they have male partners with or at high risk of acquiring HIV, and provide a novel opportunity to engage young men in PrEP delivery and as supporters of women's PrEP use.
Read the detailed description
The proposed research will engage a new cohort of young men, whose female partners are already engaged in the Kampala Women's Bone Study. Women in the Kampala Women's Bone Study will be invited to engage in this novel study to recruit their male partners. Women's HIV risk is directly related to the HIV status and risk of their male sexual partners and thus, we will leverage our ongoing cohort of KWBS young women to recruit their male sexual partners for a new men's study. Men will be offered PrEP, diagnostic STI testing and treatment, and followed for 6 months to assess PrEP continuation and STIs. Men's data will be linked to data from their female sex partners in the parallel KWBS study to determine whether women's PrEP use aligns with HIV risk and exposure.
- Study Aims Aim 1. To determine whether young women's adherence to PrEP aligns with the HIV status of their male partners Men engaging in this study will have HIV testing at enrollment, month 1 and quarterly for up to 6 months. Results from this testing will be linked to data from the participant's female sex partner that characterize her PrEP use to determine whether her PrEP use aligns with his HIV status.
Aim 2. To determine whether young women's adherence to PrEP aligns with the HIV risk of their male partners Men engaging in this study will have testing for common curable STIs (Chlamydia trachomatis and Neisseria gonorrhoeae) at enrollment, month 1 and quarterly for up to 6 months. Results from this testing will be linked to data from the participant's female sex partner that characterize her PrEP use to determine whether her PrEP use aligns with his HIV risk (defined by the results from his STI testing).
Aim 3. To determine whether young men's adherence to PrEP aligns with the HIV status and risk of their female partners We will offer PrEP to HIV-negative men enrolled in this study and track PrEP initiation, refills, and adherence to PrEP (based on self-report and drug levels). The frequency of high PrEP adherence will be compared among men with female partners infected and uninfected with HIV or another STI.
- Primary exposure The primary exposure is male infection with HIV (Aim 1), NG or CT (Aim 2) and female infection with HIV, NG, or CT (Aim 3).
- Primary outcomes The primary outcome will be PrEP used by women with sufficient daily adherence to confer HIV protection (6-7 doses in the past week or TFV ≥40ng/mL) for periods when women are dispensed PrEP. When PrEP is not dispensed, the TFV level will be assigned as 0 ng/mL.
For Aim 3, the primary outcome will be PrEP used by men with sufficient daily adherence to confer HIV protection (4 doses in the past
- Being tested
- Daily oral PrEP
- Keywords
- HIV acquisition, HIV risk, PrEP adherence
- Medical subject headings
- Sexually Transmitted Diseases, Bacterial, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily oral PrEPDrug
All participants will be offered daily oral PrEP at each visit
Daily oral PrEPDrug
All participants will be offered daily oral PrEP at each visit.
| Study group | Role | What they receive |
|---|---|---|
| Male participants | Active comparator | Male participants whose partners are enrolled in the parent study (Kampala Women's Bone study). All male participants will undergo the same study procedures at each visit, such as HIV and STI testing, and urine tenofovir testing if on PrEP. Receives: Drug: Daily oral PrEP |
| Female participants | Active comparator | Female participants from the parent study (Kampala Women's Bone study) will be enrolled to recruit their male sexual partner(s). All female participants will receive HIV testing, STI testing, and urine tenofovir testing (if on PrEP) at quarterly visits. Receives: Drug: Daily oral PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visits With PrEP Dispensation to Female Study Participants Reporting Sexual Behaviors or STI Symptoms
Percentage of visits when PrEP was dispensed to female study participants at a visit when they self-reported sexual behaviors indicating potential HIV exposure (condomless sex, multiple sexual partners, Y-chromosome detection) or STI symptoms
Measured: Six months of study participation
Visits With PrEP Dispensation to Male Study Participants Reporting Sexual Behaviors or STI Symptoms
Percentage of visits when PrEP was dispensed to male study participants at a visit when they self-reported sexual behaviors indicating potential HIV exposure (condomless sex, multiple sexual partners) or STI symptoms
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 May 2018
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The two groups are male participants enrolled in the Align study, and their sexual partners enrolled in the parent study, Kampala Women's Bone study.
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, MU-JHU CARE, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Renee Heffron, University of Washington
- Investigators
- Renee Heffron, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664998
- Sponsor's protocol ID
- STUDY00008057
- Other IDs
- R21HD098923
- Status last verified
- May 2025
- First submitted
- 18 Nov 2020
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu L, Ssebuliba T, Muwonge TR, Bambia F, Stein G, Nampewo O, Sapiri O, Goetz BJ, Penrose KJ, Parikh UM, Mujugira A, Heffron R. Alignment of PrEP Use With Potential HIV Exposure in Young Women and Men in Uganda. J Acquir Immune Defic Syndr. 2025 Apr 1;98(4):326-333. doi: 10.1097/QAI.0000000000003573. Epub 2025 Feb 19.
PubMed 39630076
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alignment of PrEP Use With HIV Risk in Young Women and Men
- ClinicalTrials.gov ID
- NCT04664998
- Acronym / sponsor ID
- STUDY00008057
- Keywords
- HIV acquisition, HIV risk, PrEP adherence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Makerere University, MU-JHU CARE, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs. In sub-Saharan Africa, young women are a priority population for HIV prevention and targeted to initiate PrEP, given their high HIV incidence rates and promising success from a strategy that can be used without the engagement of male partners. A key question in the field is whether young women using PrEP have ongoing HIV risk and adhere to PrEP sufficiently to have protection from HIV when they have condomless sex with HIV-infected partners. The only true way to know whether a heterosexual woman is sexually exposed to HIV or has a partner with high HIV risk is to test for HIV and STIs in her male partner(s) and quantify HIV viral levels, if any are detected. Yet engaging men in clinic-based HIV testing is challenging. More recent efforts have focused on using HIV self-testing kits to respond to demands on men's time and reluctance to seeking preventive healthcare. The availability of PrEP also provides a new incentive for men to test.
By leveraging an ongoing study of bone health with concurrent use of PrEP and injectable DMPA (often known as Depo Provera® or depot medroxyprogesterone acetate), we have opportunity to engage a new cohort of young men and objectively measure HIV and common STIs in these young men and link the results to women's use of PrEP. The primary objective of this study is to determine whether young women's adherence to PrEP aligns with the HIV status and risk of their male partners. To address its primary objectives, this study will leverage: 1) an ongoing study among young women and 2) a novel cohort of young men who are current sexual partners of the young women in the ongoing study to objectively measure PrEP use, HIV, and HIV factors related to HIV risk. This study will provide a framework for understanding how and when young women and men decide to take PrEP, estimate the proportion of women that are benefitting from HIV protection when they have male partners with or at high risk of acquiring HIV, and provide a novel opportunity to engage young men in PrEP delivery and as supporters of women's PrEP use.
Detailed description
The proposed research will engage a new cohort of young men, whose female partners are already engaged in the Kampala Women's Bone Study. Women in the Kampala Women's Bone Study will be invited to engage in this novel study to recruit their male partners. Women's HIV risk is directly related to the HIV status and risk of their male sexual partners and thus, we will leverage our ongoing cohort of KWBS young women to recruit their male sexual partners for a new men's study. Men will be offered PrEP, diagnostic STI testing and treatment, and followed for 6 months to assess PrEP continuation and STIs. Men's data will be linked to data from their female sex partners in the parallel KWBS study to determine whether women's PrEP use aligns with HIV risk and exposure.
- Study Aims Aim 1. To determine whether young women's adherence to PrEP aligns with the HIV status of their male partners Men engaging in this study will have HIV testing at enrollment, month 1 and quarterly for up to 6 months. Results from this testing will be linked to data from the participant's female sex partner that characterize her PrEP use to determine whether her PrEP use aligns with his HIV status.
Aim 2. To determine whether young women's adherence to PrEP aligns with the HIV risk of their male partners Men engaging in this study will have testing for common curable STIs (Chlamydia trachomatis and Neisseria gonorrhoeae) at enrollment, month 1 and quarterly for up to 6 months. Results from this testing will be linked to data from the participant's female sex partner that characterize her PrEP use to determine whether her PrEP use aligns with his HIV risk (defined by the results from his STI testing).
Aim 3. To determine whether young men's adherence to PrEP aligns with the HIV status and risk of their female partners We will offer PrEP to HIV-negative men enrolled in this study and track PrEP initiation, refills, and adherence to PrEP (based on self-report and drug levels). The frequency of high PrEP adherence will be compared among men with female partners infected and uninfected with HIV or another STI.
- Primary exposure The primary exposure is male infection with HIV (Aim 1), NG or CT (Aim 2) and female infection with HIV, NG, or CT (Aim 3).
- Primary outcomes The primary outcome will be PrEP used by women with sufficient daily adherence to confer HIV protection (6-7 doses in the past week or TFV ≥40ng/mL) for periods when women are dispensed PrEP. When PrEP is not dispensed, the TFV level will be assigned as 0 ng/mL.
For Aim 3, the primary outcome will be PrEP used by men with sufficient daily adherence to confer HIV protection (4 doses in the past
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The two groups are male participants enrolled in the Align study, and their sexual partners enrolled in the parent study, Kampala Women's Bone study.
| Arm | Type | Receives |
|---|---|---|
| Male participants | Active comparator | Drug: Daily oral PrEPMale participants whose partners are enrolled in the parent study (Kampala Women's Bone study). All male participants will undergo the same study procedures at each visit, such as HIV and STI testing, and urine tenofovir testing if on PrEP. |
| Female participants | Active comparator | Drug: Daily oral PrEPFemale participants from the parent study (Kampala Women's Bone study) will be enrolled to recruit their male sexual partner(s). All female participants will receive HIV testing, STI testing, and urine tenofovir testing (if on PrEP) at quarterly visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men ages ≥18
- Has a female sexual partner enrolled in the Kampala Women's Bone Study
- Willing and able to provide informed consent
- Participating in the Kampala Women's Bone Study
- Willing to talk with male sex partners about the new study for men and refer men for study recruitment
Key exclusion criteria (4 listed)
- Has any other condition that would preclude the ability to provide informed consent, make study participation unsafe, complicate the interpretation of study findings or otherwise interfere with achievement of the study objectives, in the investigator's discretion.
- Has concerns about potential social harm stemming from anticipated conversations with male sex partners about the new study for men such that study staff would discourage the women from participation
- Investigator discretion
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 |
|---|---|---|
| Daily oral PrEPAll participants will be offered daily oral PrEP at each visit | Drug | Female participants, Male participants |
| Daily oral PrEPAll participants will be offered daily oral PrEP at each visit. | Drug | Female participants, Male participants |
Primary outcome
Visits With PrEP Dispensation to Female Study Participants Reporting Sexual Behaviors or STI Symptoms
Time frame: Six months of study participation
Percentage of visits when PrEP was dispensed to female study participants at a visit when they self-reported sexual behaviors indicating potential HIV exposure (condomless sex, multiple sexual partners, Y-chromosome detection) or STI symptoms
Visits With PrEP Dispensation to Male Study Participants Reporting Sexual Behaviors or STI Symptoms
Time frame: Six months
Percentage of visits when PrEP was dispensed to male study participants at a visit when they self-reported sexual behaviors indicating potential HIV exposure (condomless sex, multiple sexual partners) or STI symptoms
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39630076Wu L, Ssebuliba T, Muwonge TR, Bambia F, Stein G, Nampewo O, Sapiri O, Goetz BJ, Penrose KJ, Parikh UM, Mujugira A, Heffron R. Alignment of PrEP Use With Potential HIV Exposure in Young Women and Men in Uganda. J Acquir Immune Defic Syndr. 2025 Apr 1;98(4):326-333. doi: 10.1097/QAI.0000000000003573. Epub 2025 Feb 19.
- Individual participant dataSharing planned: No
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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.
Renee Heffron, PhD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daily oral PrEP in people with Pre-Exposure Prophylaxis and Sexually Transmitted Diseases, Bacterial, run by University of Washington 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 5 inclusion and 4 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 17 Jun 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visits With PrEP Dispensation to Female Study Participants Reporting Sexual Behaviors or STI Symptoms (time frame: Six months of study participation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04664998, which also lists 1 linked publication.
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 17 Jun 2025.