Acceptability of Depo-subQ Provera 104 in Uniject vs. Intramuscular Depo-Provera Among HIV+ Women & Providers, Uganda
Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acceptability of Different Contraceptive Injection Types
Intervention: DepoSubQ Provera 104 in Uniject (Drug); Intramuscular DMPA (Drug)
Phase: N/A
Status: Completed
Sponsored by: Johns Hopkins Bloomberg School of Public Health Official(s) and/or principal investigator(s): Ron H Gray, MD, MSC, Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health
Summary
The purpose of this study is to assess acceptability and side effects of a low-dose
injectable contraceptive formulation which is delivered under the skin (subcutaneously), as
compared with injectable contraception delivered into the muscle (intramuscularly) among
adult HIV-positive women who attend mobile clinics for HIV care and wish to use injectable
contraception. The investigators will also assess experiences experiences delivering these
two types of injections among health care providers working within the HIV care clinics.
Clinical Details
Official title: Acceptability of Depo-subQ Provera 104 in Uniject Versus Intramuscular Depo-Provera Among HIV-positive Women and Family Planning Providers in Rakai, Uganda
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Preferred injection method
Secondary outcome: Acceptability, satisfaction, and problems encountered with subcutaneous injection versus intramuscular injection, as reported by HIV/family planning care providersHypothetical acceptability of contraceptive injections provided by community health care worker, trained and trusted friend or family member, or self-administration Pregnancy incidence Side effects Continuation of use of injectables Future use intentions Likelihood of recommending method to a friend Level of satisfaction with method
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- HIV+
- Woman aged 18-45
- Wishes to prevent pregnancy by use of injectable contraception and intends to
continue using injectable contraception for next nine months
- Medically eligible for injectable contraception
- Capable of providing informed consent
- Willing to provide contact information
- Agrees to trial participation
- Intends to live in the area for the next nine months
- May or may not be currently using a first-line antiretroviral therapy regimen
(includes: AZT/3TC/EFV; AZT/3TC/NVP; CBV/EFV; D4T/3TC/EFV; D4T/3TC/NVP; TDF/3TC/EFV;
TDF/3TC/NVP)
Exclusion Criteria:
- Currently pregnant
- Desires pregnancy within next nine months
- Contraindications to using injectable contraception
- On second-line antiretroviral therapy regimen
Locations and Contacts
Rakai Health Sciences Program, Kalisizo, Uganda
Additional Information
abstract
Starting date: April 2012
Last updated: September 16, 2014
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