NCT02404038

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

An Open-Label, Randomized Crossover Study to Evaluate the Acceptability and Preference for Contraceptive Options in Healthy HIV-Uninfected Female Adolescents, 16-17 Years of Age, as Proxy for HIV Prevention Methods

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Desmond Tutu HIV Centre · Academic / Other
• Sex: Female
• Age: 16 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

The family planning field has shown the importance of providing sufficient choice to meet individuals' changing needs and preferences, and has demonstrated that diversifying delivery modes and dosing options is key to expanding acceptability, use and continuation of contraceptive products. It is not yet clear to what extent choice and preference of modes of delivery will play in the biomedical HIV prevention world. It may be possible that closely associated with the behavioural components of decision to use, uptake, and consistent adherence to prevention products will hinge on a sense that a particular modality is preferred or suits an individual compared to other modalities. Vaginal rings, pills, and injectables have already proven successful in the field of contraception, and therefore may act as surrogates for a range of HIV prevention delivery options that may help to meet the different sexual and reproductive health concerns of women. A better understanding of the population of adolescents seeking contraception can also help researchers understand the acceptability and feasibility of, as well as adherence to similar modes of delivery for HIV prevention options. By using contraceptive methods as a proxy for available female-controlled HIV prevention delivery methods, such as microbicides and PrEP, we propose to examine in detail, the acceptability of these surrogates to adolescent women; their preferences for mode of delivery; and their adherence barriers and facilitators thereof to such products. Three contraceptive options will be used in this study to emulate the modes of delivery currently being developed for HIV prevention options: (1) monthly vaginal ring (NuvaRing), (2) bi-monthly injectable contraception (Nuristerate) and (3) daily dose oral contraception (Triphasil or Nordette). This is an open-label, randomized crossover study of 150 sexually active female adolescents (\>16 and \<18 years) to be recruited, with parental consent, and randomly assigned to a monthly vaginal ring, bi-monthly injectable contraception, or daily dose oral contraception at baseline. After 4 months, participants will crossover, ensuring that all participants use the vaginal ring, and either the oral contraceptive or the bi-monthly injectable contraceptive throughout the course of the study. Participants will be followed for a total of 8 months. Upon enrollment participants will be randomly assigned in a 1:1:1 ratio to one of three study arms (50 participants per arm): Arm 1/Group A: Participants will receive an injectable contraceptive once every 8 weeks for a 4 month period. Arm 2/Group B: Participants will receive the contraceptive intravaginal NuvaRing to be inserted once every 28 days (and removed after 21 days of each 28 day insertion) for a 4 month period Arm 3/Group C: Participants will be supplied with oral contraceptives and will be required to take a daily tablet for 21 days each month and a placebo tablet for days 22 to 28 each month, for a 4 month period. After 4 months, participants in Group A and Group C will be assigned to Group B; participants in Group B will be allowed to select either Groups A or Group C, ensuring that all participants use the vaginal ring, and most either the oral contraceptive or the bi-monthly injectable contraceptive. Participants will attend follow-up visits every 8 weeks throughout the duration of the study. Those participants receiving the oral contraceptive or intravaginal ring will therefore receive 8 weeks' product supply at each visit. At each visit preference / acceptability, sexual behaviour and adherence to study product will be assessed using mainly quantitative measures and general attitudes and experiences of use will be assessed in focus group discussions at the end of the study.

Conditions

• HIV

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-07-14
• Completion: 2020-02-28
• First posted: 2015-03-31
• Last updated: 2019-02-11

Locations

1 site across 1 country: South Africa