Acceptability of Depo-subQ Provera 104 in Uniject vs. Intramuscular Depo-Provera Among HIV+ Women & Providers, Uganda

Not Applicable

Completed

• Conditions: Acceptability of Different Contraceptive Injection Types
• Interventions: Drug: DepoSubQ Provera 104 in Uniject; Drug: Intramuscular DMPA

• Registration Number: NCT01578447
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-17
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 356

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Depo-SubQ Provera 104 in Uniject	DepoSubQ Provera 104 in Uniject	-
Intramuscular DMPA	Intramuscular DMPA	-

Primary Outcome Measures

Name	Time	Method
Preferred injection method	6 months	Preference for subcutaneous injection, intramuscular injection, or no preference between the two

Secondary Outcome Measures

Name	Time	Method
Acceptability, satisfaction, and problems encountered with subcutaneous injection versus intramuscular injection, as reported by HIV/family planning care providers	Baseline, 10 months	E.g., problems encountered, preference to give more, same amount, or fewer of each kind of injection, advantages and disadvantages of each kind of injection, difficulty of administration, perception of client experience, which type of injectable prefers to administer, whether preferences are impacted by HIV status of client
Hypothetical acceptability of contraceptive injections provided by community health care worker, trained and trusted friend or family member, or self-administration	Baseline, 3 months, 6 months	In this study, all injections will be provided by a trained medical professional, but we will ask women if they would hypothetically find provision by community health workers, a trained trusted friend or family member, or self-administration acceptable
Pregnancy incidence	3 months, 6 months	Will not be compared according to study product, since all participants will utilize both products in this crossover trial.
Side effects	Baseline, 3 months, 6 months	Including pain/injection/soreness at injection site and other reported side effects
Continuation of use of injectables	3 months, 6 months	Proportion of enrolled women who continue using injectable contraception at follow up visits
Future use intentions	Baseline, 3 months, 6 months	Whether plans to use injectable contraception again in three months
Likelihood of recommending method to a friend	Baseline, 3 months, 6 months	How likely participant would be to recommend this contraceptive method to a friend
Level of satisfaction with method	Baseline, 3 months, 6 months	Level of satisfaction with method of contraception injection received

Trial Locations

Locations (1)

Rakai Health Sciences Program; 🇺🇬 Kalisizo, Uganda