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

Johns Hopkins Bloomberg School of Public Health356 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

356

Conditions

Acceptability of Different Contraceptive Injection Types

Interventions

DepoSubQ Provera 104 in Uniject

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Preferred injection method

Preference for subcutaneous injection, intramuscular injection, or no preference between the two

Time frame: 6 months

Secondary Outcomes

Acceptability, satisfaction, and problems encountered with subcutaneous injection versus intramuscular injection, as reported by HIV/family planning care providers

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

Time frame: Baseline, 10 months

Hypothetical acceptability of contraceptive injections provided by community health care worker, trained and trusted friend or family member, or self-administration

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