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The PrEP (Pre-exposure Prophylaxis) SMART Study

Primary Purpose

HIV/AIDS

Status

Completed

Phase

Not Applicable

Locations

South Africa

Study Type

Interventional

Intervention

WhatsApp Group

2-way SMS

Drug level feedback

Monthly counseling sessions

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring pre-exposure prophylaxis, young women, HIV infections/prevention, SMART design

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts 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

Sites / Locations

Wits Reproductive Health and HIV Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

WhatsApp Group

2-way SMS

2-way SMS and monthly counseling sessions

2-way SMS and drug level feedback

WhatsApp Group and monthly counseling sessions

WhatsApp Group and drug level feedback

Arm Description

Participants will be assigned to participate in a WhatsApp Group

Participants will be assigned to receive weekly 2-way SMS initiated by the study team

Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions

Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback

Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions

Participants will be assigned to participate in a WhatsApp Group and drug level feedback

Outcomes

Primary Outcome Measures

PrEP Adherence

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

Secondary Outcome Measures

PrEP persistence

Assessment of the proportion of young women who achieve high adherence.

Correlates of PrEP adherence

Assessment of the correlates of PrEP adherence, after adjusting for study arm.

PrEP discontinuation

Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP.

PrEP decision making

Qualitative exploration of the factors that influence women's decisions to adhere to PrEP.

Intervention satisfaction

Qualitative exploration of women's satisfaction with their assigned intervention(s).

Full Information

NCT ID

NCT04038060

First Posted

June 19, 2019

Last Updated

August 31, 2023

Sponsor

University of Washington

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04038060

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

May 16, 2019 (Actual)

Primary Completion Date

October 27, 2021 (Actual)

Study Completion Date

January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS

Keywords

pre-exposure prophylaxis, young women, HIV infections/prevention, SMART design

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

Sequential multiple assignment randomized trial (SMART)

Masking

Investigator

Allocation

Randomized

Enrollment

350 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WhatsApp Group

Arm Type

Experimental

Arm Description

Participants will be assigned to participate in a WhatsApp Group

Arm Title

2-way SMS

Arm Type

Experimental

Arm Description

Participants will be assigned to receive weekly 2-way SMS initiated by the study team

Arm Title

2-way SMS and monthly counseling sessions

Arm Type

Experimental

Arm Description

Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions

Arm Title

2-way SMS and drug level feedback

Arm Type

Experimental

Arm Description

Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback

Arm Title

WhatsApp Group and monthly counseling sessions

Arm Type

Experimental

Arm Description

Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions

Arm Title

WhatsApp Group and drug level feedback

Arm Type

Experimental

Arm Description

Participants will be assigned to participate in a WhatsApp Group and drug level feedback

Intervention Type

Behavioral

Intervention Name(s)

WhatsApp Group

Intervention Description

Participants will receive peer adherence support through WhatsApp groups

Intervention Type

Behavioral

Intervention Name(s)

2-way SMS

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Drug level feedback

Intervention Description

Participants will receive adherence counseling based on tenofovir drug levels

Intervention Type

Behavioral

Intervention Name(s)

Monthly counseling sessions

Intervention Description

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

Primary Outcome Measure Information:

Title

PrEP Adherence

Description

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

Time Frame

9 months

Secondary Outcome Measure Information:

Title

PrEP persistence

Description

Assessment of the proportion of young women who achieve high adherence.

Time Frame

12 months

Title

Correlates of PrEP adherence

Description

Assessment of the correlates of PrEP adherence, after adjusting for study arm.

Time Frame

12 months

Title

PrEP discontinuation

Description

Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP.

Time Frame

12 months

Title

PrEP decision making

Description

Qualitative exploration of the factors that influence women's decisions to adhere to PrEP.

Time Frame

12 months

Title

Intervention satisfaction

Description

Qualitative exploration of women's satisfaction with their assigned intervention(s).

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Connie Celum, MD, MPH

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sinead Delany-Moretlwe, MBChB, PhD

Organizational Affiliation

Wits Reproductive Health and HIV Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wits Reproductive Health and HIV Institute

City

Johannesburg

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data from the PrEP SMART Study will be available at the end of the project by contacting the Principal Investigators.

Citations:

PubMed Identifier

35417485

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.

Results Reference

derived

Learn more about this trial

The PrEP (Pre-exposure Prophylaxis) SMART Study

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