HIVUChooseNCT02404038
A Study to Evaluate the Acceptability and Preference for Contraceptive Options as Proxy for HIV Prevention Methods
A study testing Nur-Isterate, Nuvaring and Triphasil in people with HIV, run by Desmond Tutu HIV Centre at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Nur-Isterate, Nuvaring and Triphasil
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2015to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Nur-Isterate, Nuvaring, Triphasil
- Keywords
- choice, young women, adolescent girls, preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nur-IsterateDrug
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).
NuvaringDevice
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.
TriphasilDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Injectable | Active comparator | This arm will receive Nur-Isterate administered as an intramuscular injection administered bi-monthly (every 8 weeks). Receives: 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. Receives: 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 Receives: Drug: Triphasil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 32 weeks
Secondary outcomes (3)
self-report, returned pill packs and rings to measure adherence to each contraceptive method
interviewer-administered questionnaire on adherence to product, pill counts and visual inspection of rings
Measured: 8 weeks, 16 weeks, 24 weeks & 32 weeks
self-reported measure of the impact of contraceptive method use on sexual risk behavior
interviewer-administered questionnaires measuring sexual risky behavior, ie. number of sexual partners, condom use, alcohol use
Measured: 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
in-depth interviews and focus group discussions with participants who used the products
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJul 2015
- Primary completion14 Jul 2017
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desmond Tutu HIV Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda-Gail Bekker, MBChB, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404038
- Sponsor's protocol ID
- Protocol A: UChoose
- Acronym
- UChoose
- Status last verified
- Feb 2019
- First submitted
- 10 Mar 2015
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37919697Happel 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.
PubMed 35348351Balle 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.
PubMed 33149114Gill 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.
PubMed 33034421Balle 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.
PubMed 32989170
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02404038
- Acronym / sponsor ID
- UChoose / Protocol A: UChoose
- Conditions
- HIV
- Keywords
- choice, young women, adolescent girls, preference
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Desmond Tutu HIV CentreUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Injectable | Active comparator | Drug: Nur-IsterateThis arm will receive Nur-Isterate administered as an intramuscular injection administered bi-monthly (every 8 weeks). |
| Arm B: Intra-vaginal | Active comparator | Device: NuvaringThis arm will receive the Nuvaring a combined hormonal contraceptive intravaginal ring, inserted once every 28 days, and removed after 21 days. |
| Arm C: Oral | Active comparator | Drug: TriphasilThis 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 |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nur-IsterateNur-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). | Drug | Arm A: Injectable |
| NuvaringNuvaring 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. | Device | Arm B: Intra-vaginal |
| TriphasilTriphasil 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 | Drug | Arm C: Oral |
Primary outcome
13-item Ortho Birth Control satisfaction assessment tool to measure acceptability of each contraceptive option
Time frame: 32 weeks
questionnaire administered after every 8 weeks on each contraceptive method
3 secondary outcomes
self-report, returned pill packs and rings to measure adherence to each contraceptive method
Time frame: 8 weeks, 16 weeks, 24 weeks & 32 weeks
self-reported measure of the impact of contraceptive method use on sexual risk behavior
Time frame: 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
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Derived from this study: PubMed 37919697Fynn 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.
- Derived from this study: PubMed 35348351Happel 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.
- Derived from this study: PubMed 33149114Balle 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.
- Derived from this study: PubMed 33034421Gill 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.
- Derived from this study: PubMed 32989170Balle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda-Gail Bekker, MBChB, PhD principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nur-Isterate, Nuvaring and Triphasil in people with HIV, run by Desmond Tutu HIV Centre at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
13-item Ortho Birth Control satisfaction assessment tool to measure acceptability of each contraceptive option (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02404038, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.