HIV/AIDS
Conditions
Brief summary
The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing for young women at high risk for HIV.
Interventions
BEHAVIORALPOPPi
behavioral intervention with offer of HIV self test
BEHAVIORALComparison
standard of care
Sponsors
MRC/UVRI and LSHTM Uganda Research Unit
Medical Research Council
London School of Hygiene and Tropical Medicine
National Institute of Mental Health (NIMH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Female age 15- to 24-years old * Engaging in high-risk sexual behavior having had sex at least once in last three months, --HlV-negative * Agree to participate in a minimum of four interviews over a 12-month period; including baseline * Willing to receive services at Good Health for Women Project (GHWP) * For those initiating PrEP (Truvada): * Participants should have immunity to Hepatitis B infection and serum creatinine before * Contra-indications for starting Truvada to be considered include Creatinine \> 1.2 ( (mgldl) or 0.106 (mmolil) and a weight below 35kg.
Exclusion criteria
* Inability to consent to participation in the study * Condition impeding participation in the study, including severe mental reason to the discretion of the principal investigator, cognitive impairment or illness; serious medical illness or developmental disability and any other reason to the discretion of the principal investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of PrEP | 6 months | Initiation of PrEP using the pharmacy records indicating PrEP received by participants. |
| Adherence to PrEP | 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. |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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 | 30 |
| Comparison participants were not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP POPPi behavioral intervention: behavioral intervention | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Intervention | Comparison | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Continuous | 19.5 years STANDARD_DEVIATION 2.1 | 19.5 years STANDARD_DEVIATION 2.3 | 19.5 years STANDARD_DEVIATION 2.2 |
| Race/Ethnicity, Customized Ugandan | 30 Participants | 30 Participants | 60 Participants |
| Region of Enrollment Uganda | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Adherence to PrEP
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.
Time frame: 12 months
Population: This is the number of participants who took PrEP and had samples tested at endline (12 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Adherence to PrEP | 19 Participants |
| Comparison | Adherence to PrEP | 18 Participants |
Primary
Initiation of PrEP
Initiation of PrEP using the pharmacy records indicating PrEP received by participants.
Time frame: 6 months
Population: Number of participants who initiated PrEP using pharmacy pill count records.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Initiation of PrEP | 18 Participants |
| Comparison | Initiation of PrEP | 21 Participants |