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

NCT02404038 | Unknown

• 1 other identifier: Protocol A: UChoose
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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

HIV

Keywords

choice; young women; adolescent girls; preference

Outcome Measures

Primary Outcomes (1)

• 13-item Ortho Birth Control satisfaction assessment tool to measure acceptability of each contraceptive option

  questionnaire administered after every 8 weeks on each contraceptive method

  32 weeks

Secondary Outcomes (3)

• self-report, returned pill packs and rings to measure adherence to each contraceptive method

  8 weeks, 16 weeks, 24 weeks & 32 weeks

• self-reported measure of the impact of contraceptive method use on sexual risk behavior

  baseline, 8 weeks, 16 weeks, 24 weeks & 32 weeks

• qualitative measures of perceptions on key issues associated with each method of contraceptive measured in focus group discussions

  8 months

Other Outcomes (1)

• through self-reports and interviewer-administered questionnaires explore how perceptions may be extrapolated to ART based HIV prevention methods

  8 months

Study Arms (3)

Arm A: Injectable

ACTIVE COMPARATOR

This arm will receive Nur-Isterate administered as an intramuscular injection administered bi-monthly (every 8 weeks).

Drug: Nur-Isterate

Arm B: Intra-vaginal

ACTIVE COMPARATOR

This arm will receive the Nuvaring a combined hormonal contraceptive intravaginal ring, inserted once every 28 days, and removed after 21 days.

Device: Nuvaring

Arm C: Oral

ACTIVE COMPARATOR

This arm will receive Triphasil a daily oral contraceptive of 21 active tablets followed by 7 inert tablets, starting initially on first day of menstrual cycle

Drug: Triphasil

Interventions

Nur-Isterate DRUG

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).

Arm A: Injectable

Nuvaring DEVICE

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.

Arm B: Intra-vaginal

Triphasil DRUG

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

Arm C: Oral

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 16 to 17 years (inclusive) at screening, verified per study site SOPs.
• Able and willing to provide written informed consent and has a guardian who is able and willing to provide written informed consent to be screened for and to take part in the study.
• Report being sexually active, as defined by penetrative vaginal sex in the last 90 days.
• (For those potential participants who are currently using a method of hormonal contraception) Reports being within 30 days or less of needing a new supply of contraception; agrees to terminate her current method of contraception; and indicates willingness to use the contraceptive options as assigned in the study.
• Able and willing to provide adequate locator information, as defined in site SOPs.
• HIV-uninfected based on testing performed by study staff at screening and enrollment.
• Has negative pregnancy test at screening and enrollment and per participant report, does not intend to become pregnant in the next 8 months.
• Agrees to use condoms, in addition to the assigned contraception options, for the duration of the study
• Does not report intention to relocate out of the study area during the course of the study.
• At Screening/ Enrollment, participant states a willingness to refrain from inserting any non-study vaginal products or objects into the vagina, including but not limited to, spermicides, diaphragms, contraceptive vaginal rings (besides the Nuvaring), vaginal medications, menstrual cups, cervical caps (or any other vaginal barrier method), douches, lubricants, sex toys (vibrators, dildos, etc) throughout the duration of study participation.
• Does not have job or other obligations that would require long absences from the area (\> 8 weeks at a time).
• Willing to undergo all study-required procedures.
• At screening and enrollment, agrees not to participate in other research studies involving medical devices or vaginal products for the next 32 weeks

You may not qualify if:

• Diagnosed with pelvic inflammatory disease, a sexually transmitted infection (STI) or reproductive tract infection (RTI) requiring treatment per current WHO guidelines.
• Note: Otherwise eligible participants diagnosed with STI or RTI during screening will be offered treatment and may be enrolled after completing treatment and all symptoms have resolved.
• Urine dipstick for protein and glucose, of more than \> 1+.
• Any Grade \> 2 toxicity on screening tests and assessments.
• Has any other condition that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
• Known allergy or sensitivity to the study products.
• Demonstrates intent or desire to conceive in the next 32 weeks.
• Appears psychologically unstable, intoxicated or under the influence of alcohol or other drugs at the time of informed consent.
• Has any other condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• Has hormonal contraceptive implant device or an intrauterine contraceptive device.

Sponsors & Collaborators

• Desmond Tutu HIV Centre: lead

Study Sites (1)

Desmond Tutu HIV Centre

Cape Town, South Africa

Location

Related Publications (5)

• Fynn L, Gill K, Wallace M, Atujuna M, Duyver M, Ngcobo P, Spiegel H, Rinehart A, Hosek S, Bekker LG. "It's already in your body and it's preventing": a qualitative study of African female adolescent's acceptability and preferences for proxy HIV prevention methods in Cape Town, South Africa. BMC Public Health. 2023 Nov 2;23(1):2143. doi: 10.1186/s12889-023-16955-3.

  PMID: 37919697 DERIVED

• Happel AU, Gasper M, Balle C, Konstantinus I, Gamieldien H, Dabee S, Gill K, Bekker LG, Passmore JS, Jaspan HB. Persistent, Asymptomatic Colonization with Candida is Associated with Elevated Frequencies of Highly Activated Cervical Th17-Like Cells and Related Cytokines in the Reproductive Tract of South African Adolescents. Microbiol Spectr. 2022 Apr 27;10(2):e0162621. doi: 10.1128/spectrum.01626-21. Epub 2022 Mar 29.

  PMID: 35348351 DERIVED

• Balle C, Konstantinus IN, Jaumdally SZ, Havyarimana E, Lennard K, Esra R, Barnabas SL, Happel AU, Moodie Z, Gill K, Pidwell T, Karaoz U, Brodie E, Maseko V, Gamieldien H, Bosinger SE, Myer L, Bekker LG, Passmore JS, Jaspan HB. Hormonal contraception alters vaginal microbiota and cytokines in South African adolescents in a randomized trial. Nat Commun. 2020 Nov 4;11(1):5578. doi: 10.1038/s41467-020-19382-9.

  PMID: 33149114 DERIVED

• Gill K, Happel AU, Pidwell T, Mendelsohn A, Duyver M, Johnson L, Meyer L, Slack C, Strode A, Mendel E, Fynn L, Wallace M, Spiegel H, Jaspan H, Passmore JA, Hosek S, Smit D, Rinehart A, Bekker LG. An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose). J Int AIDS Soc. 2020 Oct;23(10):e25626. doi: 10.1002/jia2.25626.

  PMID: 33034421 DERIVED

• Balle C, Gill K, Konstantinus IN, Jaumdally SZ, Lennard K, Esra R, Happel AU, Barnabas SL, Gamieldien H, Pidwell T, Maseko V, Lesosky M, Myer L, Passmore JS, Bekker LG, Jaspan HB. Hormonal contraception and risk of STIs and bacterial vaginosis in South African adolescents: secondary analysis of a randomised trial. Sex Transm Infect. 2021 Mar;97(2):112-117. doi: 10.1136/sextrans-2020-054483. Epub 2020 Sep 28.

  PMID: 32989170 DERIVED

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Linda-Gail Bekker, MBChB, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 31, 2015
• Study Start: July 1, 2015
• Primary Completion: July 14, 2017
• Study Completion: February 28, 2020
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

ZA (1)