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A Study to Evaluate the Acceptability and Preference for Contraceptive Options as Proxy for HIV Prevention Methods

NCT02404038 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2019-02-11

No results posted yet for this study

Summary

This study will enrol sexually active, healthy girls aged 16-17 to assess and compare the acceptability and preference for a monthly vaginal ring, bi-monthly injectable contraception or daily dose oral contraception, as proxy for female-controlled ARV-based HIV prevention methods.

Conditions

Interventions

DRUG

Nur-Isterate

Nur-Isterate is a progestogen-only injectable contraceptive (POIC) is a long-acting, reversible contraceptive. Nur-Isterate is administered as an intramuscular injection administered bi-monthly (every 8 weeks). Each ampoule of Nur-Isterate contains 1ml/200mg of norethisterone enantate (17alpha-ethinyl-17beta-heptanoyloxy-4-estrene-3-one).

DEVICE

Nuvaring

Nuvaring is the trade name for a combined hormonal contraceptive intravaginal ring, inserted once every 28 days, and removed after 21 days. The flexible plastic ring works in a similar way to the oral contraceptive pill to prevent pregnancy. It contains etonogestrel/ethinyl estradion and delivers 0.120mg/0.015mg per day.

DRUG

Triphasil

Triphasil is a daily oral contraceptive: 21 active tablets followed by 7 inert tablets, starting initially on first day of menstrual cycle Composition: The six brown tablets of TRIPHASIL contain 30 µg ethinyl oestradiol and 50 µg levonorgestrel. The five white tablets contain 40 µg ethinyl oestradiol and 75 µg levonorgestrel. The ten yellow tablets contain 30 µg ethinyl oestradiol and 125 µg levonorgestrel. The seven red tablets are inert

Sponsors & Collaborators

  • Desmond Tutu HIV Centre

    lead OTHER

Principal Investigators

  • Linda-Gail Bekker, MBChB, PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-07-14
Completion
2020-02-28

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02404038 on ClinicalTrials.gov