The PrEP (Pre-exposure Prophylaxis) SMART Study
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ClinicalTrials.gov Identifier: NCT04038060 |
Recruitment Status :
Recruiting
First Posted : July 30, 2019
Last Update Posted : September 30, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV/AIDS | Behavioral: WhatsApp Group Behavioral: 2-way SMS Behavioral: Drug level feedback Behavioral: Monthly counseling sessions | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Sequential multiple assignment randomized trial (SMART) |
Masking: | Single (Investigator) |
Primary Purpose: | Prevention |
Official Title: | Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design |
Actual Study Start Date : | May 16, 2019 |
Estimated Primary Completion Date : | November 1, 2021 |
Estimated Study Completion Date : | March 1, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: WhatsApp Group
Participants will be assigned to participate in a WhatsApp Group
|
Behavioral: WhatsApp Group
Participants will receive peer adherence support through WhatsApp groups |
Experimental: 2-way SMS
Participants will be assigned to receive weekly 2-way SMS initiated by the study team
|
Behavioral: 2-way SMS
Participants will receive healthcare worker adherence support through 2-way SMS |
Experimental: 2-way SMS and monthly counseling sessions
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
|
Behavioral: 2-way SMS
Participants will receive healthcare worker adherence support through 2-way SMS Behavioral: Monthly counseling sessions Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence |
Experimental: 2-way SMS and drug level feedback
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
|
Behavioral: 2-way SMS
Participants will receive healthcare worker adherence support through 2-way SMS Behavioral: Drug level feedback Participants will receive adherence counseling based on tenofovir drug levels |
Experimental: WhatsApp Group and monthly counseling sessions
Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
|
Behavioral: WhatsApp Group
Participants will receive peer adherence support through WhatsApp groups Behavioral: Monthly counseling sessions Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence |
Experimental: WhatsApp Group and drug level feedback
Participants will be assigned to participate in a WhatsApp Group and drug level feedback
|
Behavioral: WhatsApp Group
Participants will receive peer adherence support through WhatsApp groups Behavioral: Drug level feedback Participants will receive adherence counseling based on tenofovir drug levels |
- PrEP Adherence [ Time Frame: 9 months ]Evaluation of the proportion of young women who adhere well to PrEP in each of the intervention arms.
- PrEP persistence [ Time Frame: 12 months ]Assessment of the proportion of young women who achieve high adherence.
- Correlates of PrEP adherence [ Time Frame: 12 months ]Assessment of the correlates of PrEP adherence, after adjusting for study arm.
- PrEP discontinuation [ Time Frame: 12 months ]Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP.
- PrEP decision making [ Time Frame: 12 months ]Qualitative exploration of the factors that influence women's decisions to adhere to PrEP.
- Intervention satisfaction [ Time Frame: 12 months ]Qualitative exploration of women's satisfaction with their assigned intervention(s).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 25 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038060
Contact: Jennifer Morton, MPH, MSW | 12065203832 | jfmorton@uw.edu | |
Contact: Jennifer Velloza, PhD, MPH | 206-520-3800 | jvelloza@uw.edu |
South Africa | |
Wits Reproductive Health and HIV Institute | Recruiting |
Johannesburg, South Africa | |
Contact: Sinead Delany-Moretlwe, MBHcB, PhD |
Principal Investigator: | Connie Celum, MD, MPH | University of Washington | |
Principal Investigator: | Sinead Delany-Moretlwe, MBChB, PhD | Wits Reproductive Health and HIV Institute |
Responsible Party: | Connie Celum, Prof of Medicine & Global Health, Adjunct Prof of Epidemiology, University of Washington |
ClinicalTrials.gov Identifier: | NCT04038060 |
Other Study ID Numbers: |
STUDY00006439 R01MH114544 ( U.S. NIH Grant/Contract ) |
First Posted: | July 30, 2019 Key Record Dates |
Last Update Posted: | September 30, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data from the PrEP SMART Study will be available at the end of the project by contacting the Principal Investigators. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
pre-exposure prophylaxis young women HIV infections/prevention SMART design |
Acquired Immunodeficiency Syndrome HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |