The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis (HCBV)
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|ClinicalTrials.gov Identifier: NCT02905890|
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis HIV||Drug: Norethisterone enantate Device: Condoms||Phase 4|
Bacterial vaginosis (BV) is highly prevalent among women in Africa and is associated with HIV acquisition. BV has been described as a dysbiosis, or a microbial imbalance, and is treated with metronidazole; however, once treated, it often recurs rapidly. Developing robust treatment strategies to prevent recurrent BV is important for HIV prevention in key populations at high risk for HIV infection.
There is evidence that hormonal contraceptives, including depot medroxyprogesterone acetate (DMPA), decrease BV recurrence; however, there is also evidence that DMPA increases the risk of HIV infection. Encouraging women to start or switch to an alternative progestin injectable such as norethisterone enantate (NET-EN) may mitigate HIV risk whilst decreasing the risk of recurrent BV. To date, there are no published studies that have investigated the effect of NET-EN on vaginal microbiota.
The proposed study will investigate the effect of NET-EN and DMPA on recurrent BV, vaginal microbiota and inflammatory markers among women at high risk for HIV in the Good Health for Women Project in Kampala, Uganda. Consenting and eligible women will be treated for BV, and randomised to either NET-EN plus condoms or condoms only. Women currently using DMPA will be enrolled as an observational comparison arm. All participants will be interviewed and examined; samples for vaginal microbiota, sexually transmitted infections, and inflammatory markers will be obtained. Women will be followed up after 1 week, and 1, 2, 3, 4 and 6 months. The primary outcomes will be differences in vaginal microbiota clusters, time to recurrent BV, and inflammatory markers. Qualitative research will be carried out to assess the acceptability of, and adherence to, NET-EN.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||525 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hormonal Contraception and Bacterial Vaginosis (HCBV): The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis Among Women at High Risk for HIV Infection in Kampala, Uganda|
|Actual Study Start Date :||October 2, 2017|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: Norethisterone enanthate plus condoms
200 mg Norethisterone enanthate intramuscularly every eight weeks at enrolment, 2 and 4 months. Counseling and condoms will be provided at enrolment, 1, 2, 3 and 4 months.
Drug: Norethisterone enantate
Noristerat® 200mg, solution for intramuscular injection given every 8 weeks
Other Name: NoristeratDevice: Condoms
Latex male condoms
Active Comparator: Condoms only
Counseling and condoms will be provided at enrolment, 1, 2, 3 and 4 months.
Latex male condoms
- Time to diagnosis of recurrent BV [ Time Frame: 6 months ]
- Proportional of participants with Lactobacillus-dominant cluster [ Time Frame: 6 months ]
- Concentration of markers for inflammation [ Time Frame: 6 months ]Twenty-four soluble immune proteins will be quantified by in-house multiplex bead immunoassay including interleukin(IL)-1α, IL1β, IL-2, IL4, IL-6, IL-7, IL- 8, IL-12, IL-15, IL16, IFN-g, MIP-1β, SDF1β, TNF-α, IP-10, RANTES, GM-CSF, G-CSF, MIG, IFN- -β, TGF-β, MCP-1, MCP-2, MIP-3α and other immune proteins as appropriate.
- Acceptability of norethisterone enanthate as measured by qualitative interviews [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905890
|Contact: Suzanna C Francis, MSc MPH PHD||+44 0207 927 firstname.lastname@example.org|
|Contact: Sarah Harman||+44 0207 927 2483||Sarah.Harman@lshtm.ac.uk|
|MRC/UVRI Mengo Clinic and Research Station||Recruiting|
|Contact: Janet Seeley, PhD Janet.Seeley@lshtm.ac.uk|
|Contact: Yunia Mayanja, MD Yunia.Mayanja@mrcuganda.org|
|Principal Investigator:||Suzanna C Francis, MSc MPH PHD||London School of Hygiene and Tropical Medicine|