Phase 3
N=372
Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01691768 ↗Enrolled (actual)
372
Serious AEs
8.1%
Results posted
Nov 2019
Primary outcome: Primary: Mean Number of Returned Used Applicators Per Month (i.e in 30 Days) — 5.2; 5.7; 5.5; 5.8 Used gel applicators per month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 1% tenofovir gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Returned Used Applicators Per Month (i.e in 30 Days) |
5.2; 5.7; 5.5; 5.8 | — |
| SECONDARY HIV Incidence Rates |
3.5; 3.6 | 0.928 |
| SECONDARY Pregnancy Incidence Rates |
4.9; 5.1 | 0.895 |
| SECONDARY Percentage of Participants Achieving Adherence >80%. |
70.2; 65.2 | 0.304 |
| SECONDARY HIV Viral Load Among HIV Seroconverters |
4.4; 4.8 | 0.455 |
| SECONDARY Tenofovir Resistance Among HIV Seroconverters |
— | — |
| SECONDARY Human Papillomavirus Incidence Rates |
1.0; 3.0 | 0.097 |
| SECONDARY Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up |
39.5; 43.6 | 0.462 |
| SECONDARY Product Acceptability |
180; 170 | — |
Summary
The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.
Eligibility Criteria
Inclusion Criteria
- Age 18 years and older
- Women who previously participated in an ARV prevention study
- Currently utilizing or agreeing to attend designated public sector family planning services
- Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
- Able and willing to provide adequate locator information for study retention purposes
- Sexually active (at least one coital act in the last 3 months prior to screening)
- HIV negative (by HIV testing performed by study staff within 30 days of enrollment)
- Negative pregnancy test performed by study staff within 21 days of enrollment
- Agree to use a non-barrier form of contraceptive
- Agree to adhere to study visits and procedures
Exclusion Criteria
- Has a creatinine clearance < 50ml/min
- Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Data sourced from ClinicalTrials.gov (NCT01691768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.