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

• Status: Unknown status
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Desmond Tutu HIV Centre
• Treatments: Contraceptive Agents; Contraceptives, Oral; Ethinyl Estradiol-Norgestrel Combination; Ethinyl estradiol, levonorgestrel drug combination; NuvaRing

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.