Clinical trial NCT02905890: The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Vaginosis
HIV
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: University of Liverpool
name: MRC/UVRI and LSHTM Uganda Research Unit
First posted: 2016-09-19
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study, Hormonal Contraception \& BV (HCBV), 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 Kampala, Uganda. The hypothesis is that NET-EN will show a similar beneficial effect on recurrent BV and vaginal microbiota as DMPA, without inducing signs of mucosal inflammation.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BV positive by Nugent score
* HIV negative
* Capable of providing written informed consent

Exclusion Criteria:

* Currently pregnant or using a reliable contraception (e.g. injectables, intrauterine devices, implant, oral contraceptive pills)
* Desiring pregnancy in the next year
* History of tubal ligation or hysterectomy
* Contraindication to progestin-only contraceptives
* Unable to comprehend consent material because of language barrier or psychological difficulty

Primary outcomes:
measure: Time to diagnosis of recurrent BV
timeFrame: 6 months
Secondary outcomes:
measure: Proportional of participants with Lactobacillus-dominant cluster
timeFrame: 6 months
measure: Concentration of markers for inflammation
timeFrame: 6 months
measure: Acceptability of norethisterone enanthate as measured by qualitative interviews
timeFrame: 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: MRC/UVRI Mengo Clinic and Research Station
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Suzanna C Francis, MSc MPH PHD
role: PRINCIPAL_INVESTIGATOR
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