ART Readiness in HIV-infected Pregnant Women: From Formative Qualitative Research to Individual Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 1
- 主要终点
- Proportion of women who both initiate ART and are retained in care
研究概览
简要总结
This study seeks to evaluate the readiness of HIV-infected pregnant women in Zambia to initiate, adhere to, and be retained in care under the Ministry of Health's Option B+ policy. Under a 3-phased research study the investigators will: (1) conduct formative research regarding readiness to start lifelong ART in the pregnant population; (2) translate the results of formative research into a readiness assessment tool and an enhanced adherence package for pregnant women eligible for Option B+ and (3) conduct an individual randomized trial of the enhanced adherence package.
详细描述
This is qualitative and quantitative research exploring the issues of patient readiness to initiate lifelong ART among HIV-infected pregnant women, as well as ART adherence and retention in HIV care and treatment during pregnancy and after delivery.
The objectives of Phase 1 of the study are as follows:
- To identify common themes about patient readiness for ART initiation in the days and weeks following ART eligibility in the context of pregnancy
- To learn about strategies that HIV-infected women and partners of reproductive-age women believe will assist with daily adherence to triple-drug ART and retention in care during pregnancy and after delivery
The objectives of Phase 2 of the study are as follows:
- To develop a screening instrument for assessing readiness of ART initiation during pregnancy
- To pilot the ART readiness assessment tool and evaluate its acceptability and feasibility through qualitative research
- To design a combination intervention that systematically addresses barriers to patient readiness and in so doing, may shorten time from HIV diagnosis to ART initiation and increase rates of ART adherence and retention in care in the short term
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected pregnant women not yet on ART OR
- •HIV-infected pregnant or postnatal women on ART OR
- •Partners of women who were recently or are currently pregnant
排除标准
- •Less than 18 years old
- •Known history of mental illness
- •Inclusion Criteria:
- •HIV-infected pregnant or postnatal women on ART who piloted tested the readiness assessment tool OR
- •Health care workers involved in provision of PMTCT and/or ART services at health facility who have pilot tested the readiness assessment tool
- •Inclusion Criteria:
- •HIV-infected
- •Never previously initiated or was on ART for her own health
- •Able to provide informed consent
- •Willing to undergo all study tests and procedures and be followed until 6 months post-partum
- •Exclusion criteria:
- •Less than 18 years old
- •Known intrauterine fetal demise
- •Known history of mental illness
- •Does not intend to receive antenatal care, labour and delivery care, and postnatal care at the government health facilities of Lusaka District
结局指标
主要结局
Proportion of women who both initiate ART and are retained in care
时间窗: Within 30 days of eligibility to begin ART under Option B+ policy
ART eligibility in the setting of Option B+ will generally be either the date of HIV diagnosis for pregnant women newly diagnosed with HIV infection during their antenatal care visit or the date of their first antenatal care visit for known HIV-infected pregnant women who are not already on ART
HIV virologic suppression at time of delivery
时间窗: Time of delivery
Outcome of virologic suppression at delivery will be analyzed for differences between the SOC arm and intervention arm.
次要结局
- Time from ART eligibility to ART initiation(Time from ART eligibility to initiation from enrollment until 6 months post-partum)
- HIV transmission from mother to infant(At 6 weeks and 6 months of life)