Acceptability of Depo-subQ Provera 104 in Uniject Versus Intramuscular Depo-Provera Among HIV-positive Women and Family Planning Providers in Rakai, Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Preferred injection method
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Currently pregnant
- •Desires pregnancy within next nine months
- •Contraindications to using injectable contraception
- •On second-line antiretroviral therapy regimen
研究组 & 干预措施
Depo-SubQ Provera 104 in Uniject
干预措施: DepoSubQ Provera 104 in Uniject (Drug)
Intramuscular DMPA
干预措施: Intramuscular DMPA (Drug)
结局指标
主要结局
Preferred injection method
时间窗: 6 months
Preference for subcutaneous injection, intramuscular injection, or no preference between the two
次要结局
- Acceptability, satisfaction, and problems encountered with subcutaneous injection versus intramuscular injection, as reported by HIV/family planning care providers(Baseline, 10 months)
- 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)
- Pregnancy incidence(3 months, 6 months)
- Side effects(Baseline, 3 months, 6 months)
- Continuation of use of injectables(3 months, 6 months)
- Future use intentions(Baseline, 3 months, 6 months)
- Likelihood of recommending method to a friend(Baseline, 3 months, 6 months)
- Level of satisfaction with method(Baseline, 3 months, 6 months)
研究者
Ronald Gray
Professor
Johns Hopkins Bloomberg School of Public Health