Clinical trial NCT01578447: Acceptability of Depo-subQ Provera 104 in Uniject vs. Intramuscular Depo-Provera Among HIV+ Women & Providers, Uganda
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acceptability of Different Contraceptive Injection Types
Keywords: injectable contraception
acceptability
intramuscular
subcutaneous
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
name: Bill and Melinda Gates Foundation
name: Rakai Health Sciences Program
First posted: 2012-04-17
Enrollment: 356
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.


Eligibility 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

Primary outcomes:
measure: Preferred injection method
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability, satisfaction, and problems encountered with subcutaneous injection versus intramuscular injection, as reported by HIV/family planning care providers
timeFrame: Baseline, 10 months
measure: Hypothetical acceptability of contraceptive injections provided by community health care worker, trained and trusted friend or family member, or self-administration
timeFrame: Baseline, 3 months, 6 months
measure: Pregnancy incidence
timeFrame: 3 months, 6 months
measure: Side effects
timeFrame: Baseline, 3 months, 6 months
measure: Continuation of use of injectables
timeFrame: 3 months, 6 months
measure: Future use intentions
timeFrame: Baseline, 3 months, 6 months
measure: Likelihood of recommending method to a friend
timeFrame: Baseline, 3 months, 6 months
measure: Level of satisfaction with method
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Kalisizo
country: Uganda
facility: Rakai Health Sciences Program
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Ron H Gray, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polis CB, Nakigozi GF, Nakawooya H, Mondo G, Makumbi F, Gray RH; Members of the Rakai Health Sciences Program Sayana Press study team. Preference for Sayana(R) Press versus intramuscular Depo-Provera among HIV-positive women in Rakai, Uganda: a randomized crossover trial. Contraception. 2014 May;89(5):385-95. doi: 10.1016/j.contraception.2013.11.008. Epub 2013 Nov 15.