Trial Outcomes & Findings for Alignment of PrEP Use With HIV Risk in Young Women and Men (NCT NCT04664998)
NCT ID: NCT04664998
Last Updated: 2025-06-17
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
212 participants
Primary outcome timeframe
Six months of study participation
Results posted on
2025-06-17
Participant Flow
Participant milestones
| Measure |
Male Participants
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.
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit.
|
Female Participants
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.
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
88
|
|
Overall Study
COMPLETED
|
124
|
88
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alignment of PrEP Use With HIV Risk in Young Women and Men
Baseline characteristics by cohort
| Measure |
Male Participants
n=124 Participants
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.
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit.
|
Female Participants
n=88 Participants
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.
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit.
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.5 years
n=99 Participants
|
20.6 years
n=107 Participants
|
22 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
124 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Uganda
|
124 participants
n=99 Participants
|
88 participants
n=107 Participants
|
212 participants
n=206 Participants
|
|
PrEP dispensation at first visit
|
75 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Six months of study participationPercentage 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
Outcome measures
| Measure |
% Female Participant Visits When PrEP Dispensed
n=332 Visits
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.
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit.
|
|---|---|
|
Visits With PrEP Dispensation to Female Study Participants Reporting Sexual Behaviors or STI Symptoms
|
211 Visits
|
PRIMARY outcome
Timeframe: Six monthsPercentage 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
Outcome measures
| Measure |
% Female Participant Visits When PrEP Dispensed
n=241 Visits
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.
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit
Daily oral PrEP: All participants will be offered daily oral PrEP at each visit.
|
|---|---|
|
Visits With PrEP Dispensation to Male Study Participants Reporting Sexual Behaviors or STI Symptoms
|
151 Visits
|
Adverse Events
Male Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Female Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place