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NCT Number: NCT04038060

The PrEP (Pre-exposure Prophylaxis) SMART Study

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wits Reproductive Health and HIV Institute

Johannesburg, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whatsapp group

Behavioral

Participants will receive peer adherence support through WhatsApp groups

2-way SMS

Behavioral

Participants will receive healthcare worker adherence support through 2-way SMS

Drug level feedback

Behavioral

Participants will receive adherence counseling based on tenofovir drug levels

Monthly counseling sessions

Behavioral

Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence

Primary outcomes

  1. PrEP Adherence

    Time frame: 9 months

    Evaluation of the proportion of young women who adhere well to PrEP in each of the original intervention arms.

Secondary outcomes

  1. Probability of High PrEP Adherence at Nine Months

    Time frame: 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.

  2. PrEP Discontinuation

    Time frame: 9 months

    Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP, reported by original intervention arm.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Wits Reproductive Health and HIV Institute

Registry information

Official study title

Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 30, 2019
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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