Clinical Trial on the Effects of Progestin-based Contraception in the Genital Tract of HIV-infected and Uninfected Women

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02103660
• Date of registration: 01/04/2014
• Prospective Registration: Yes
• Primary sponsor: Centers for Disease Control and Prevention
• Public title: Clinical Trial on the Effects of Progestin-based Contraception in the Genital Tract of HIV-infected and Uninfected Women
• Scientific title: A Randomized Clinical Trial on the Effects of Progestin-based Contraception in the Genital Tract of HIV-infected and Uninfected Women
• Date of first enrolment: April 8, 2014
• Target sample size: 131
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02103660
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Malawi

Contacts

• Name: Lameck Chinula, MD
• Affiliation: UNC-Project Lilongwe

• Name: Athena P Kourtis, MD, PhD, MPH
• Affiliation: Centers for Disease Control and Prevention

• Name: Jennifer Tang, MD, MSCR
• Affiliation: University of North Carolina

Key inclusion & exclusion criteria

Inclusion Criteria:

- Known HIV status, as documented by at least 2 concordant rapid tests (Determine and
Uni-Gold, respectively). If the 2 rapid tests are discordant, then a confirmatory test
will be done via Western blot.

- Female, pre-menopausal, age 18 to 45 years

- At least 2 regular, monthly cycles (~21-35 days) in the 3 months preceding study
enrollment.

- If on hormonal or intrauterine contraception in the past, they must have been off for
at least 6 months. If they were previously using DMPA, their last -injection must have
been =6 months ago.

- If recently pregnant, they must be at least 6 months postpartum

- Able and willing to provide informed consent

- Be otherwise a good candidate for study participation based on assessment by
investigator or designee

- Interested in initiating a family planning method, specifically depot
medroxyprogesterone acetate (DMPA) or the LNG implant (Jadelle)

- Willing to be randomized to receive either DMPA or LNG implant (Jadelle)

- Willing to wait 4-6 weeks after enrollment to receive this method and to use
non-hormonal and non-intrauterine methods (such as abstinence or condoms) consistently
during this period

Exclusion Criteria:

- Pregnancy (by clinical history or a positive urine pregnancy test at screening)

- Women currently using any hormonal contraceptive method

- Desire pregnancy within next 12 months

- Untreated visible genital ulcers or lesions on initial pelvic examination

- Known or suspected genital tract cancer (by clinical history or noted during initial
pelvic examination).

- Contraindications to DMPA or LNG implant per the WHO medical eligibility114 criteria
or judgment of clinician (contraindications include lactation within first 6 weeks
postpartum, acute deep venous thrombosis or pulmonary embolism, lupus, migraine with
aura, unexplained vaginal bleeding, current or history of breast cancer, severe
cirrhosis, liver tumors, history of stroke, current or history of ischemic heart
disease).

- Acute HIV infection (as documented by a known negative HIV test 6 months or less prior
to screening).



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Contraception

HIV

Intervention(s)

Drug: Progestin Contraceptive (Jadelle)

Drug: Depo-Medroxyprogesterone Acetate

Primary Outcome(s)

HIV viral load in the genital tract of HIV-infected women by contraceptive type [Time Frame: 6 months post randomization;24 months to 33 months post randomization]

HIV viral load in the genital tract of HIV-infected women before and after initiation of progestin-containing contraception [Time Frame: 6 months post randomization; 24 months to 33 months post randomization]

Secondary Outcome(s)

Impact of the type of progestin-containing contraception (injectable versus implant) on inflammatory/immune markers in the genital tract women. [Time Frame: 6 months post randomization]

Contraceptive efficacy in HIV-infected women [Time Frame: 6 months post randomization; 24 months to 33 months post randomization]

Interaction of progestin-based hormonal contraception and antiretroviral therapy [Time Frame: 6 months post randomization;24 months to 33 months post randomization]

Secondary ID(s)

SIP 09-022

1K01TW009657-01

CDC-NCCDPHP-6512

U48DP001944

UNCPM 1303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bill and Melinda Gates Foundation

United States Agency for International Development (USAID)

Fogarty International Center of the National Institute of Health

National Institutes of Health (NIH)