Clinical trial NCT04038060: The PrEP (Pre-exposure Prophylaxis) SMART Study
Official title: Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: pre-exposure prophylaxis
young women
HIV infections/prevention
SMART design
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Wits Reproductive Health and HIV Institute
name: National Institute of Mental Health (NIMH)
First posted: 2019-07-30
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential multiple assignment randomized trial (SMART)
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP Adherence
timeFrame: 9 months
Secondary outcomes:
measure: PrEP persistence
timeFrame: 12 months
measure: Correlates of PrEP adherence
timeFrame: 12 months
measure: PrEP discontinuation
timeFrame: 12 months
measure: PrEP decision making
timeFrame: 12 months
measure: Intervention satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health and HIV Institute
Study officials:
affiliation: University of Washington
name: Connie Celum, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wits Reproductive Health and HIV Institute
name: Sinead Delany-Moretlwe, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Velloza J, Poovan N, Ndlovu N, Khoza N, Morton JF, Omony J, Mkwanazi E, Grabow C, Donnell D, Munthali R, Baeten JM, Hosek S, Celum C, Delany-Moretlwe S. Adaptive HIV pre-exposure prophylaxis adherence interventions for young South African women: Study protocol for a sequential multiple assignment randomized trial. PLoS One. 2022 Apr 13;17(4):e0266665. doi: 10.1371/journal.pone.0266665. eCollection 2022.