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The PrEP (Pre-exposure Prophylaxis) SMART Study

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University of Washington

Status

Completed

Conditions

HIV/AIDS

Treatments

Behavioral: Monthly counseling sessions
Behavioral: WhatsApp Group
Behavioral: Drug level feedback
Behavioral: 2-way SMS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04038060
R01MH114544 (U.S. NIH Grant/Contract)
STUDY00006439

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 patients

Sex

Female

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

350 participants in 6 patient groups

WhatsApp Group
Experimental group
Description:
Participants will be assigned to participate in a WhatsApp Group
Treatment:
Behavioral: WhatsApp Group
2-way SMS
Experimental group
Description:
Participants will be assigned to receive weekly 2-way SMS initiated by the study team
Treatment:
Behavioral: 2-way SMS
2-way SMS and monthly counseling sessions
Experimental group
Description:
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
Treatment:
Behavioral: Monthly counseling sessions
Behavioral: 2-way SMS
2-way SMS and drug level feedback
Experimental group
Description:
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
Treatment:
Behavioral: Drug level feedback
Behavioral: 2-way SMS
WhatsApp Group and monthly counseling sessions
Experimental group
Description:
Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
Treatment:
Behavioral: WhatsApp Group
Behavioral: Monthly counseling sessions
WhatsApp Group and drug level feedback
Experimental group
Description:
Participants will be assigned to participate in a WhatsApp Group and drug level feedback
Treatment:
Behavioral: WhatsApp Group
Behavioral: Drug level feedback

Trial contacts and locations

1

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Central trial contact

Jennifer Morton, MPH, MSW; Jennifer Velloza, PhD, MPH

Data sourced from clinicaltrials.gov

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