Trial Outcomes & Findings for Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda (NCT NCT04030520)

NCT ID: NCT04030520

Last Updated: 2025-07-15

Results Overview

Initiation of PrEP using the pharmacy records indicating PrEP received by participants.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

6 months

Results posted on

2025-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP POPPi behavioral intervention: behavioral intervention with offer of HIV self test	Comparison participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP POPPi behavioral intervention: behavioral intervention
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=30 Participants participants received a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP POPPi behavioral intervention: behavioral intervention with offer of HIV self test	Comparison n=30 Participants participants were not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP POPPi behavioral intervention: behavioral intervention	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=99 Participants	14 Participants n=107 Participants	28 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=99 Participants	16 Participants n=107 Participants	32 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	19.5 years STANDARD_DEVIATION 2.1 • n=99 Participants	19.5 years STANDARD_DEVIATION 2.3 • n=107 Participants	19.5 years STANDARD_DEVIATION 2.2 • n=206 Participants
Sex: Female, Male Female	30 Participants n=99 Participants	30 Participants n=107 Participants	60 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Ugandan	30 Participants n=99 Participants	30 Participants n=107 Participants	60 Participants n=206 Participants
Region of Enrollment Uganda	30 participants n=99 Participants	30 participants n=107 Participants	60 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Number of participants who initiated PrEP using pharmacy pill count records.

Initiation of PrEP using the pharmacy records indicating PrEP received by participants.

Outcome measures

Outcome measures
Measure	Intervention n=30 Participants number of participants initiating PrEP	Comparison n=30 Participants number of participants initiating PrEP
Initiation of PrEP	18 Participants	21 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This is the number of participants who took PrEP and had samples tested at endline (12 months)

Adherence to PrEP using hair analysis measured by the concentration of antiretroviral drug in strands of hair. The results will be measured per participant using concentration in nanograms/milligrams. The number of participants who showed a positive drug concentration in nanograms/milligrams is reported.

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants number of participants initiating PrEP	Comparison n=20 Participants number of participants initiating PrEP
Adherence to PrEP	19 Participants	18 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparison

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

Dr Rachel King

University of California San Francisco

Phone: +256785304516

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place