Trial Outcomes & Findings for Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study (NCT NCT02732730)
NCT ID: NCT02732730
Last Updated: 2025-06-12
Results Overview
Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
451 participants
Primary outcome timeframe
at month 6 from start of the study
Results posted on
2025-06-12
Participant Flow
Out of 451 enrolled participants 427 accepted PrEP and 24 Declined. The outcomes are based on PrEP acceptors (427). Hence the total participants shown below is out of 427.
Participant milestones
| Measure |
Standard Adherence Support
212 women who choose to accept PrEP (Truvada) and assigned to receive standard adherence support.
|
Enhanced Adherence Support
215 women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support.
|
|---|---|---|
|
Overall Study
STARTED
|
212
|
215
|
|
Overall Study
Retention at 6 Months
|
188
|
183
|
|
Overall Study
COMPLETED
|
184
|
179
|
|
Overall Study
NOT COMPLETED
|
28
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
Baseline characteristics by cohort
| Measure |
Standard Adherence Support
n=212 Participants
For those women who choose to accept PrEP (Truvada) and assigned to standard adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
|
Enhanced Adherence Support
n=215 Participants
For those women who choose to accept PrEP (Truvada) and assigned to enhanced adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
* Drug level counseling at Weeks 8 and 13
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21 years
n=5 Participants
|
21 years
n=7 Participants
|
21 years
n=5 Participants
|
|
Age, Customized
16-17 years
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Customized
18-21 years
|
112 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Age, Customized
22-25 years
|
89 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
427 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Zimbabwe-Shona
|
70 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Zimbabwe-Ndebele
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Zimbabwe-Other African Group
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Zimbabwe-White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Zimbabwe-Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Africa-White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Africa-Black
|
139 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Africa-Indian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Africa-Coloured
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Africa-Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
139 participants
n=5 Participants
|
143 participants
n=7 Participants
|
282 participants
n=5 Participants
|
|
Region of Enrollment
Zimbabwe
|
73 participants
n=5 Participants
|
72 participants
n=7 Participants
|
145 participants
n=5 Participants
|
|
Total VOICE Score
|
7 units on a scale
n=5 Participants
|
7 units on a scale
n=7 Participants
|
7 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: at month 6 from start of the studyPopulation: Among population who accepted PrEP, retained at month 6 and had detectable tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS)
Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch
Outcome measures
| Measure |
Enhanced Adherence Support
n=179 Participants
For those women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
* Drug level counseling at Weeks 8 and 13
* Retention at month 6
* With DBS available
Truvada: 400 women who accept to initiate PrEP
Drug level counseling at Weeks 8 and 13: Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance
|
Standard Adherence Support
n=184 Participants
For those women who choose to accept PrEP (Truvada) and assigned to receive standard adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
* Retention at month 6
* With DBS available Truvada: 400 women who accept to initiate PrEP
|
|---|---|---|
|
Number of Participants With High Adherence at Six Months
|
36 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 12 months from the start of the studyPopulation: Patients who accepted PrEP, retained at 12 months and had detectable tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS)
Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch
Outcome measures
| Measure |
Enhanced Adherence Support
n=173 Participants
For those women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
* Drug level counseling at Weeks 8 and 13
* Retention at month 6
* With DBS available
Truvada: 400 women who accept to initiate PrEP
Drug level counseling at Weeks 8 and 13: Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance
|
Standard Adherence Support
n=174 Participants
For those women who choose to accept PrEP (Truvada) and assigned to receive standard adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
* Retention at month 6
* With DBS available Truvada: 400 women who accept to initiate PrEP
|
|---|---|---|
|
Number of Participants With High Adherence at Twelve Months
|
12 Participants
|
18 Participants
|
Adverse Events
Standard Adherence Support
Serious events: 2 serious events
Other events: 98 other events
Deaths: 0 deaths
Enhanced Adherence Support
Serious events: 5 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Adherence Support
n=212 participants at risk
For those women who choose to accept PrEP (Truvada) and assigned to receive standard adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
Truvada: 400 women who accept to initiate PrEP
|
Enhanced Adherence Support
n=215 participants at risk
For those women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
* Drug level counseling at Weeks 8 and 13
Truvada: 400 women who accept to initiate PrEP
Drug level counseling at Weeks 8 and 13: Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/212 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
0.47%
1/215 • Number of events 1 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Infections and infestations
Appendicitis
|
0.00%
0/212 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
0.47%
1/215 • Number of events 1 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/212 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
0.47%
1/215 • Number of events 1 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/212 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
0.47%
1/215 • Number of events 1 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Infections and infestations
Pyelonephritis
|
0.47%
1/212 • Number of events 1 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
0.00%
0/215 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Psychiatric disorders
Intentional self-injury
|
0.47%
1/212 • Number of events 1 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
0.00%
0/215 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/212 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
0.47%
1/215 • Number of events 1 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
Other adverse events
| Measure |
Standard Adherence Support
n=212 participants at risk
For those women who choose to accept PrEP (Truvada) and assigned to receive standard adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
Truvada: 400 women who accept to initiate PrEP
|
Enhanced Adherence Support
n=215 participants at risk
For those women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
* Drug level counseling at Weeks 8 and 13
Truvada: 400 women who accept to initiate PrEP
Drug level counseling at Weeks 8 and 13: Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.47%
1/212 • Number of events 1 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
0.00%
0/215 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.47%
1/212 • Number of events 1 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
0.00%
0/215 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Investigations
Blood creatinine increased
|
2.8%
6/212 • Number of events 7 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
2.3%
5/215 • Number of events 5 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Investigations
Creatinine renal clearance decreased
|
45.3%
96/212 • Number of events 107 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
43.7%
94/215 • Number of events 106 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
|
Investigations
Weight decreased
|
0.94%
2/212 • Number of events 2 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
1.4%
3/215 • Number of events 3 • From the start of the treatment until the resolution of all Adverse Events after completion of discontinuity of the study treatment (Up till 1 year after the start of the study treatment)
For the purposes of this study, only serious adverse events (SAEs) and adverse events Grade 3 and above \[with the exception of Creatinine Clearance, which will be measured using the Schwartz Equation and documented at Grade 2 or higher\].
|
Additional Information
HPTN Statistical Manager
HPTN Statistical & Data Management Center
Phone: 206-667-4004
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place