HIV
Conditions
Keywords
ART (Antir-retroviral therapy), PrEP (Pre-Exposure Prophylaxis), DAIDS (Division of AIDS), HPTN (HIV Prevention Trials Network)
Brief summary
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
Detailed description
A Phase IV randomized multi-site prospective study to assess PrEP acceptance and adherence among HIV-uninfected young women. All women who accept open-label daily oral PrEP will be randomized 1:1 to receive enhanced adherence counselling based on feedback from observed drug levels or standard adherence support. A subset of up to \ 25 women per site (maximum 75), will participate in qualitative assessments of facilitators and barriers for PrEP acceptance, adherence and continuation.
Interventions
DRUGTruvada
400 women who accept to initiate PrEP
BEHAVIORALDrug level counseling at Weeks 8 and 13
Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance
Sponsors
National Institutes of Health (NIH)
Gilead Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
Young women who meet all of the following criteria are eligible for inclusion in this study: * Female at birth * Age 16-25 years * Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening * Literate in one or more of the study languages * Willing and able to provide informed consent or assent (if parental consent is required per local regulations) * If parental consent is required per local regulations, parent/legal guardian willing and able to consent to all study procedures including HIV testing * Able and willing to provide adequate locator information, as defined in site Standard Operating Procedures (SOPs) * Have a score of 5 or greater on the Vaginal and Oral Intervention to Control the Epidemic (VOICE) risk score tool * Interest in PrEP (ascertained by selected questions from the HIV Prevention Readiness Measure (HPRM) and Prep Belief Measure (PBM) defined in the Study Specific Procedures \[SSP\] Manual) * Regular access to a mobile phone with SMS capacity * Agrees not to participate in other research studies involving drugs or medical devices for the next 12 months * Hepatitis B virus (HBV) seronegative and accepts HBV vaccination.
Exclusion criteria
Young women who meet any of the following criteria will be excluded from this study: * Planning to relocate in the next 12 months * Has a job or other obligations that would require long absences from the area (\> 4 weeks at a time) for 12 months * Any health condition that may interfere with participation, including any debilitating or life-threatening conditions * Currently pregnant or planning to become pregnant in the next 12 months * Any reactive or positive HIV test at Screening or Enrollment, even if subsequent testing indicates that the person is HIV-uninfected * Renal dysfunction (Creatinine Clearance \< 60 ml/min, Schwartz Equation) * Any reported PrEP use within the last 12 months * Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents * Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial * Signs or symptoms of acute HIV infection (as described in the SSP Manual) * Current active and serious infections which could interfere with study participation, including active tuberculosis infection, osteomyelitis, and all infections requiring parenteral antibiotic therapy (other than STIs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly-controlled cardiac disease (e.g., symptoms of ischemia, congestive heart failure), or previously diagnosed malignancy expected to require further treatment. * Current use of ARV drugs for post-exposure prophylaxis (PEP) or completion of a PEP regimen within 4 weeks prior to Screening * History of pathological bone fracture not related to trauma * Known allergy/sensitivity to the study drug or its components * Receiving ongoing therapy with any of the following: investigational ARV agents, interferon or interleukin therapy, agents with substantial nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents * Any other condition that, based on the opinion of the site Investigator of Record (IoR) or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With High Adherence at Six Months | at month 6 from start of the study | Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With High Adherence at Twelve Months | 12 months from the start of the study | Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch |
Countries
South Africa, Zimbabwe
Participant flow
Pre-assignment details
Out of 451 enrolled participants 427 accepted PrEP and 24 Declined. The outcomes are based on PrEP acceptors (427). Hence the total participants shown below is out of 427.
Participants by arm
| Arm | Count |
|---|---|
| Standard Adherence Support For those women who choose to accept PrEP (Truvada) and assigned to standard adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs | 212 |
| Enhanced Adherence Support For those women who choose to accept PrEP (Truvada) and assigned to enhanced adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
* Drug level counseling at Weeks 8 and 13 | 215 |
| Total | 427 |
Baseline characteristics
| Characteristic | Standard Adherence Support | Enhanced Adherence Support | Total |
|---|---|---|---|
| Age, Continuous | 21 years | 21 years | 21 years |
| Age, Customized 16-17 years | 11 Participants | 16 Participants | 27 Participants |
| Age, Customized 18-21 years | 112 Participants | 127 Participants | 239 Participants |
| Age, Customized 22-25 years | 89 Participants | 72 Participants | 161 Participants |
| Race/Ethnicity, Customized South Africa-Black | 139 Participants | 143 Participants | 282 Participants |
| Race/Ethnicity, Customized South Africa-Coloured | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized South Africa-Indian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized South Africa-Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized South Africa-White | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Zimbabwe-Ndebele | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Zimbabwe-Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Zimbabwe-Other African Group | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Zimbabwe-Shona | 70 Participants | 66 Participants | 136 Participants |
| Race/Ethnicity, Customized Zimbabwe-White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 139 participants | 143 participants | 282 participants |
| Region of Enrollment Zimbabwe | 73 participants | 72 participants | 145 participants |
| Sex: Female, Male Female | 212 Participants | 215 Participants | 427 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Total VOICE Score | 7 units on a scale | 7 units on a scale | 7 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 212 | 0 / 215 |
| other Total, other adverse events | 98 / 212 | 97 / 215 |
| serious Total, serious adverse events | 2 / 212 | 5 / 215 |
Outcome results
Primary
Number of Participants With High Adherence at Six Months
Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch
Time frame: at month 6 from start of the study
Population: Among population who accepted PrEP, retained at month 6 and had detectable tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Adherence Support | Number of Participants With High Adherence at Six Months | 36 Participants |
| Standard Adherence Support | Number of Participants With High Adherence at Six Months | 40 Participants |
Secondary
Number of Participants With High Adherence at Twelve Months
Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch
Time frame: 12 months from the start of the study
Population: Patients who accepted PrEP, retained at 12 months and had detectable tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Adherence Support | Number of Participants With High Adherence at Twelve Months | 12 Participants |
| Standard Adherence Support | Number of Participants With High Adherence at Twelve Months | 18 Participants |