A Study to Evaluate the Acceptability and Preference for Contraceptive Options as Proxy for HIV Prevention Methods
Information source: Desmond Tutu HIV Centre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV
Intervention: Nur-Isterate (Drug); Nuvaring (Device); Triphasil (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Desmond Tutu HIV Centre Official(s) and/or principal investigator(s): Linda-Gail Bekker, MBChB, PhD, Principal Investigator, Affiliation: University of Cape Town
Overall contact: Melissa Wallace, PhD, Phone: +27 021 6506961, Email: Melissa.Wallace@hiv-research.org.za
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: 13-item Ortho Birth Control satisfaction assessment tool to measure acceptability of each contraceptive option
Secondary outcome: self-report, returned pill packs and rings to measure adherence to each contraceptive methodself-reported measure of the impact of contraceptive method use on sexual risk behavior qualitative measures of perceptions on key issues associated with each method of contraceptive measured in focus group discussions
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.
Eligibility
Minimum age: 16 Years.
Maximum age: 17 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Age 16 to 17 years (inclusive) at screening, verified per study site SOPs.
2. 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.
3. Report being sexually active, as defined by penetrative vaginal sex in the last 90
days.
4. (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.
5. Able and willing to provide adequate locator information, as defined in site SOPs.
6. HIV-uninfected based on testing performed by study staff at screening and enrollment.
7. Has negative pregnancy test at screening and enrollment and per participant report,
does not intend to become pregnant in the next 8 months.
8. Agrees to use condoms, in addition to the assigned contraception options, for the
duration of the study
9. Does not report intention to relocate out of the study area during the course of the
study.
10. 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.
11. Does not have job or other obligations that would require long absences from the area
(> 8 weeks at a time).
12. Willing to undergo all study-required procedures.
13. At screening and enrollment, agrees not to participate in other research studies
involving medical devices or vaginal products for the next 32 weeks
Exclusion Criteria:
1. 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.
2. Urine dipstick for protein and glucose, of more than > 1+.
3. Any Grade > 2 toxicity on screening tests and assessments.
4. 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.
5. Known allergy or sensitivity to the study products.
6. Demonstrates intent or desire to conceive in the next 32 weeks.
7. Appears psychologically unstable, intoxicated or under the influence of alcohol or
other drugs at the time of informed consent.
8. 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.
9. Has hormonal contraceptive implant device or an intrauterine contraceptive device.
Locations and Contacts
Melissa Wallace, PhD, Phone: +27 021 6506961, Email: Melissa.Wallace@hiv-research.org.za
Desmond Tutu HIV Centre, Cape Town, South Africa; Recruiting Katherine M Gill, MBChB, Phone: +27 21 785 3121, Email: katherine.gill@hiv-research.org.za Cleopatra Jaars, MA, Phone: +27 21 785 3121, Email: Cleopatra.Jaars@hiv-research.org.za Linda-Gail Bekker, MBChB, PhD, Principal Investigator
Additional Information
Starting date: July 2015
Last updated: August 12, 2015
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