NCT02179138

Brief Summary

To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural KwaZulu-Natal, South Africa.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

June 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

First QC Date

June 27, 2014

Last Update Submit

April 9, 2015

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (4)

  • Overall acceptability

    Overall acceptability of user-filled, paper applicator compared to prefilled, plastic applicator

    over 3 months of use

  • context of use

    Description of context of use of user-filled, paper applicator

    over three months

  • challenges encountered

    Challenges encountered during use of user-filled, paper applicator and recommendations to address challenges

    over three months

  • Applicator Preference

    Applicator preferences between the user-filled, paper applicator and prefilled, plastic applicator

    Over three months

Study Arms (1)

TFV 1% Gel

OTHER

TFV 1% gel with the user-filled paper applicator

Drug: TFV 1% gel

Interventions

TFV 1% gelDRUG
TFV 1% Gel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Women who previously participated in CAPRISA 008
  • Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
  • Allow access to their CAPRISA 008 data, including study exit data
  • 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
  • Negative pregnancy test \*
  • Agree to use a non-barrier form of contraceptive
  • Agree to adhere to study visits and procedures

You may not qualify if:

  • Has creatinine clearance ,\<50ml/min, as estimated using the method of Cockcroft and Gault
  • 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 the study outcome data, or otherwise interfere with achieving the study objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAPRISA Vulindlela Clinical Research Site

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

MeSH Terms

Interventions

Gels

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Leila E Mansoor, Ph.D.

    Centre for the AIDS Programme of Research in South Africa

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2014

First Posted

July 1, 2014

Primary Completion

March 1, 2015

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

ZA(1)