HIV/AIDS
Conditions
Keywords
pre-exposure prophylaxis, young women, HIV infections/prevention, SMART design
Brief summary
The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.
Detailed description
Women enrolled in the study will be randomized to standard of care adherence support (brief counseling) and either WhatsApp groups or weekly two-way SMS messages. Two months after PrEP initiation, tenofovir drug levels will be measured to determine if participants have achieved high adherence based on their initial randomization. Women with high adherence (i.e., TFV-DP \>/=500 fmol/punch from dried blood spots \[DBS\]) will continue with the adherence support to which they were initially randomized. Participants with low adherence (i.e., TFV-DP \<500 fmol/punch from DBS) will continue initial randomization (WhatsApp or two-way SMS) plus be randomized to more one of two more intensive adherence support interventions - continued monthly visits with adherence and problem-focused counseling at months 3-8 or quarterly visits between months 3-9 with feedback about adherence based on drug levels at months 3 and 6.
Interventions
BEHAVIORALWhatsApp Group
Participants will receive peer adherence support through WhatsApp groups
BEHAVIORAL2-way SMS
Participants will receive healthcare worker adherence support through 2-way SMS
BEHAVIORALDrug level feedback
Participants will receive adherence counseling based on tenofovir drug levels
BEHAVIORALMonthly counseling sessions
Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence
Sponsors
University of Washington
Wits Reproductive Health and HIV Institute
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Intervention model description
Sequential multiple assignment randomized trial (SMART)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Female at birth * Age 18-25 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 * Able and willing to provide adequate locator information * Regular access to a mobile phone with SMS and WhatsApp capacity * Agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation
Exclusion criteria
* 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 * A reactive or positive HIV test at Enrollment * Any reported PrEP use within the last 6 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 * Positive pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence | 9 months | Evaluation of the proportion of young women who adhere well to PrEP in each of the original intervention arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probability of High PrEP Adherence at Nine Months | 9 months | Estimated probability of high PrEP adherence (tenofovir diphosphate levels greater than or equal to 700 fmol/punch at 9 months) by embedded dynamic treatment strategy. This analysis employed a weighted and replicated approach to account for non-response, re-randomization, and overlap in intervention assignments (e.g., the same participants in the SMS intervention were represented twice in two of the four interventions). Weighting accounted for over-representation of people who responded, whereas replicating responder observations across the two embedded dynamic treatment strategies with the same first-line treatment accounted for one participant being able to be in two treatment strategies. |
| PrEP Discontinuation | 9 months | Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP, reported by original intervention arm. |
Countries
South Africa
Contacts
PRINCIPAL_INVESTIGATORConnie Celum, MD, MPH
University of Washington
PRINCIPAL_INVESTIGATORSinead Delany-Moretlwe, MBChB, PhD
Wits Reproductive Health and HIV Institute
Participant flow
Pre-assignment details
Participants were initially randomized to either 2 way SMS or the WhatsApp group. At the M3 follow up visit participants who were no responders to the primary randomization were then randomized to either drug level feedback counseling or monthly counseling visits.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 360 Participants |
| Age, Continuous | 21.5 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment South Africa | 360 participants |
| Sex: Female, Male Female | 360 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 180 | 0 / 180 |
| other Total, other adverse events | 0 / 180 | 0 / 180 |
| serious Total, serious adverse events | 0 / 180 | 0 / 180 |
Outcome results
None listed