Trial Outcomes & Findings for The PrEP (Pre-exposure Prophylaxis) SMART Study (NCT NCT04038060)
NCT ID: NCT04038060
Last Updated: 2026-05-04
Results Overview
Evaluation of the proportion of young women who adhere well to PrEP in each of the original intervention arms.
COMPLETED
NA
360 participants
9 months
2026-05-04
Participant Flow
Participants were initially randomized to either 2 way SMS or the WhatsApp group. At the M3 follow up visit participants who were no responders to the primary randomization were then randomized to either drug level feedback counseling or monthly counseling visits.
Participant milestones
| Measure |
WhatsApp Group Responders (no Second Randomization)
Participants will be assigned to participate in a WhatsApp Group
WhatsApp Group: Participants will receive peer adherence support through WhatsApp groups
|
2-way SMS Plus Drug Level Feedback Non Responders
Participants were originally assigned to 2-way SMS but were randomized again at M3 to receive adherence counseling based on tenofovir drug levels
|
2-way SMS Plus Monthly Counseling Sessions Non-responders
Participants were originally assigned to receive weekly 2-way SMS initiated by the study team, at M3 they were assigned monthly counseling sessions on a variety of issues that may be impacting their PrEP adherence.
|
WhatsApp Group Plus Drug Level Feedback Non-responders
Participants were originally assigned to participate in a WhatsApp Group and at M3 were assigned to receive adherence counseling based on tenofovir drug levels.
|
WhatsApp Group Plus Monthly Counseling Sessions Non-responders
Participants were assigned to participate in a WhatsApp Group and at M3 were assigned to receive monthly counseling sessions on a variety of issues that may be impacting their PrEP adherence.
|
2-way SMS Responders (no Second Randomization)
Participants will be assigned to receive weekly 2-way SMS initiated by the study team
2-way SMS: Participants will receive healthcare worker adherence support through 2-way SMS
|
|---|---|---|---|---|---|---|
|
Month 0 - Month 3
STARTED
|
180
|
0
|
0
|
0
|
0
|
180
|
|
Month 0 - Month 3
COMPLETED
|
175
|
0
|
0
|
0
|
0
|
176
|
|
Month 0 - Month 3
NOT COMPLETED
|
5
|
0
|
0
|
0
|
0
|
4
|
|
Month 3 - Month 9
STARTED
|
105
|
42
|
43
|
35
|
35
|
91
|
|
Month 3 - Month 9
COMPLETED
|
92
|
31
|
28
|
23
|
25
|
80
|
|
Month 3 - Month 9
NOT COMPLETED
|
13
|
11
|
15
|
12
|
10
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
2-Way SMS
n=180 Participants
Participants in this arm will be randomized to receive 2-way SMS. If at 3 months they are responding they continue in their original arm. If non-responding, they have an additional randomization to monthly counseling visits or drug-level feedback counseling.
|
WhatsApp Groups
n=180 Participants
Participants in this arm will be randomized to join a WhatsApp group. If at 3 months they are responding they continue in their original arm. If non-responding, they have an additional randomization to monthly counseling visits or drug-level feedback counseling.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
180 Participants
n=180 Participants
|
180 Participants
n=180 Participants
|
360 Participants
n=360 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Age, Continuous
|
21.0 years
n=180 Participants
|
21.5 years
n=180 Participants
|
21.0 years
n=360 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=180 Participants
|
180 Participants
n=180 Participants
|
360 Participants
n=360 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=180 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=360 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
180 participants
n=180 Participants
|
180 participants
n=180 Participants
|
360 participants
n=360 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: The results show the number of participants who had TFV-DP results of greater than or equal to 700 fmol/punch at their 9 month visit, based on their original randomization arm.
Evaluation of the proportion of young women who adhere well to PrEP in each of the original intervention arms.
Outcome measures
| Measure |
WhatsApp, With Addition of Drug-level Feedback Counseling for Non-responders
Participants will be assigned to participate in a WhatsApp Group and drug level feedback
WhatsApp Group: Participants will receive peer adherence support through WhatsApp groups
Drug level feedback: Participants will receive adherence counseling based on tenofovir drug levels
|
2-Way SMS
n=132 Participants
Participants in this arm will be randomized to receive 2-way SMS. If at 3 months they are responding they continue in their original arm. If non-responding, they have an additional randomization to monthly counseling visits or drug-level feedback counseling.
|
WhatsApp Groups
n=134 Participants
Participants in this arm will be randomized to join a WhatsApp group. If at 3 months they are responding they continue in their original arm. If non-responding, they have an additional randomization to monthly counseling visits or drug-level feedback counseling.
|
WhatsApp, With Addition of Monthly Counseling for Non-responders
Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
WhatsApp Group: Participants will receive peer adherence support through WhatsApp groups
Monthly counseling sessions: Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence
|
|---|---|---|---|---|
|
PrEP Adherence
|
—
|
34 Participants
|
32 Participants
|
—
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Analysis conducted among all participants who were retained and had data at Month 9. Population includes responders and non-responders to compare flow of outcomes among simulated population. Participants are grouped by embedded dynamic treatment strategy. See Outcome Measure Description for notes on weighting and double-counting.
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.
Outcome measures
| Measure |
WhatsApp, With Addition of Drug-level Feedback Counseling for Non-responders
n=140 Participants
Participants will be assigned to participate in a WhatsApp Group and drug level feedback
WhatsApp Group: Participants will receive peer adherence support through WhatsApp groups
Drug level feedback: Participants will receive adherence counseling based on tenofovir drug levels
|
2-Way SMS
n=134 Participants
Participants in this arm will be randomized to receive 2-way SMS. If at 3 months they are responding they continue in their original arm. If non-responding, they have an additional randomization to monthly counseling visits or drug-level feedback counseling.
|
WhatsApp Groups
n=133 Participants
Participants in this arm will be randomized to join a WhatsApp group. If at 3 months they are responding they continue in their original arm. If non-responding, they have an additional randomization to monthly counseling visits or drug-level feedback counseling.
|
WhatsApp, With Addition of Monthly Counseling for Non-responders
n=140 Participants
Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
WhatsApp Group: Participants will receive peer adherence support through WhatsApp groups
Monthly counseling sessions: Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence
|
|---|---|---|---|---|
|
Probability of High PrEP Adherence at Nine Months
|
0.24 Probability of high PrEP Adherence
Interval 0.17 to 0.33
|
0.25 Probability of high PrEP Adherence
Interval 0.18 to 0.34
|
0.27 Probability of high PrEP Adherence
Interval 0.19 to 0.36
|
0.24 Probability of high PrEP Adherence
Interval 0.17 to 0.33
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Number of participants who had at least one PrEP discontinuation at Month 9, reported by original randomization group.
Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP, reported by original intervention arm.
Outcome measures
| Measure |
WhatsApp, With Addition of Drug-level Feedback Counseling for Non-responders
Participants will be assigned to participate in a WhatsApp Group and drug level feedback
WhatsApp Group: Participants will receive peer adherence support through WhatsApp groups
Drug level feedback: Participants will receive adherence counseling based on tenofovir drug levels
|
2-Way SMS
n=180 Participants
Participants in this arm will be randomized to receive 2-way SMS. If at 3 months they are responding they continue in their original arm. If non-responding, they have an additional randomization to monthly counseling visits or drug-level feedback counseling.
|
WhatsApp Groups
n=180 Participants
Participants in this arm will be randomized to join a WhatsApp group. If at 3 months they are responding they continue in their original arm. If non-responding, they have an additional randomization to monthly counseling visits or drug-level feedback counseling.
|
WhatsApp, With Addition of Monthly Counseling for Non-responders
Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
WhatsApp Group: Participants will receive peer adherence support through WhatsApp groups
Monthly counseling sessions: Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence
|
|---|---|---|---|---|
|
PrEP Discontinuation
|
—
|
19 Participants
|
18 Participants
|
—
|
Adverse Events
2-Way SMS
WhatsApp Groups
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Velloza
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place