NCT03142256

Brief Summary

This study has two phases. It will be conducted in one site in CT only. Phase I is to enumerate interest in PrEP uptake among young South African women exposed to a culturally-appropriate social marketing campaign. This enumeration will also serve as a recruitment strategy for a cohort with open-label PrEP access in Phase II. The cohort will assess PrEP acceptability and adherence among 200 HIV-uninfected young women who are offered open-label daily oral PrEP and randomized to receive or not receive a short term cash incentive conditional on study drug adherence.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2017

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

March 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

March 3, 2017

Last Update Submit

February 14, 2019

Conditions

Adherence

Outcome Measures

Primary Outcomes (1)

  • Drug adherence

    200 women measuring cash incentive for drug adherence with half the Cohort

    3 months

Study Arms (2)

Incentivised - Conditional Cash Transfer

ACTIVE COMPARATOR

Cash incentive for good drug levels assed by Dried Blood Spot

Behavioral: Incentivised - Conditional Cash TransferDrug: Truvada 200Mg-300Mg Tablet

No incentive

NO INTERVENTION

Truvada 200Mg-300Mg Tablet

Interventions

Incentivised - Conditional Cash TransferBEHAVIORAL

Participant will be randomized to receive a cash transfer conditional on drug levels at months 1, 2, and 3 versus no cash transfer

Also known as: Truvada 200Mg-300Mg Tablet
Incentivised - Conditional Cash Transfer
Truvada 200Mg-300Mg TabletDRUG

Both study arms will be offered Truvada as PrEP. Only one arm will be randomized to the conditional cash transfer.

Also known as: Incentivised - Conditional Cash Transfer
Incentivised - Conditional Cash Transfer

Eligibility Criteria

Age16 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female at birth
  • HIV uninfected at screening and enrollment
  • Age 16-25 years old at screening, inclusive
  • Per participant report, sexually active, defined as having vaginal or anal intercourse with a male partner at least once in the month prior to screening
  • Willing and able to provide informed consent
  • Able and willing to provide adequate locator information

You may not qualify if:

  • Not planning to be in the area for periods longer than a month in the first three months and longer than 3 months from Month 3 - 12
  • A positive HIV test at Enrollment, even if subsequent testing indicates that the person is HIV-1 uninfected
  • Renal dysfunction (Creatinine Clearance \<60 mL/min, Cockroft Gault equation)
  • Previous participation in an oral PrEP study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Desmond Tutu HIV Foundation

Cape Town, Western Cape, 7975, South Africa

Location

Desmond Tutu HIV Centre

Cape Town, South Africa

Location

Related Publications (2)

  • Celum CL, Gill K, Morton JF, Stein G, Myers L, Thomas KK, McConnell M, van der Straten A, Baeten JM, Duyver M, Mendel E, Naidoo K, Dallimore J, Wiesner L, Bekker LG. Incentives conditioned on tenofovir levels to support PrEP adherence among young South African women: a randomized trial. J Int AIDS Soc. 2020 Nov;23(11):e25636. doi: 10.1002/jia2.25636.

    PMID: 33247553DERIVED

  • Morton JF, Myers L, Gill K, Bekker LG, Stein G, Thomas KK, Duyver M, van der Straten A, McConnell M, Aunger R, Curtis V, de Witt Huberts J, Van Damme L, Baeten JM, Celum C. Evaluation of a behavior-centered design strategy for creating demand for oral PrEP among young women in Cape Town, South Africa. Gates Open Res. 2020 Jul 3;4:29. doi: 10.12688/gatesopenres.13103.2. eCollection 2020.

    PMID: 32411946DERIVED

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

TenofovirOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2017

First Posted

May 5, 2017

Study Start

March 24, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ZA(2)