The PrEP (Pre-exposure Prophylaxis) SMART Study

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038060
• Other study ID #: STUDY00006439
• Secondary ID: R01MH114544
• Status: Completed
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: January 25, 2022

Study information

• Verified date: August 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 25, 2022
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• WhatsApp Group
Participants will receive peer adherence support through WhatsApp groups
• 2-way SMS
Participants will receive healthcare worker adherence support through 2-way SMS
• Drug level feedback
Participants will receive adherence counseling based on tenofovir drug levels
• Monthly counseling sessions
Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence

Locations

Country	Name	City	State
South Africa	Wits Reproductive Health and HIV Institute	Johannesburg

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH), Wits Reproductive Health and HIV Institute

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP Adherence	Evaluation of the proportion of young women who adhere well to PrEP in each of the intervention arms.	9 months
Secondary	PrEP persistence	Assessment of the proportion of young women who achieve high adherence.	12 months
Secondary	Correlates of PrEP adherence	Assessment of the correlates of PrEP adherence, after adjusting for study arm.	12 months
Secondary	PrEP discontinuation	Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP.	12 months
Secondary	PrEP decision making	Qualitative exploration of the factors that influence women's decisions to adhere to PrEP.	12 months
Secondary	Intervention satisfaction	Qualitative exploration of women's satisfaction with their assigned intervention(s).	12 months