Assessing the Effectiveness and Feasibility of Voluntary Assisted Partner Notification Services in High HIV Burden Districts of Malawi: a Pragmatic, Non-Randomized Stepped-Wedge Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,785
- 试验地点
- 1
- 主要终点
- Proportion of eligible index clients offered VAPN services
研究概览
简要总结
To evaluate effectiveness of voluntary assisted partner notification (VAPN) in real-world programmatic settings, a non-randomized, stepped wedge study in high volume facilities in 6 high HIV burden focus districts (Blantyre, Zomba, Chikwawa, Machinga, Mangochi and Lilongwe urban) is proposed. The primary objective is to compare the percentage of contacts tested during the standard of care (SOC) phase (i.e., using passive family referral services (FRS) index testing methodology) with the percentage of contacts tested during the SOC plus VAPN phase, by 1, 2, and 3 months after the initial contact with the index client. Assessment of feasibility will be achieved through documentation of operational lessons learned during implementation. Findings will contribute to ongoing policy discussions whether Malawi should adopt VAPN in its national HIV testing guidelines
详细描述
The over-arching goal of this study is to evaluate the effectiveness and feasibility of the voluntary assisted partner notification (VAPN) intervention in real-world programmatic settings in high burden facilities in 6 priority districts in Malawi.
The primary objective is to compare effectiveness of standard of care (SOC) (i.e., use of the family referral services (FRS)) with SOC plus VAPN in reaching contacts of index clients with HIV testing services. The percentage of contacts who receive HIV testing services within 1, 2, and 3 months of the initial offer of services to the index client will be compared between the SOC phase and the intervention phase (SOC plus VAPN).
Secondary objectives include:
- To evaluate feasibility of implementing VAPN in real-world programmatic settings in high burden facilities in 6 priority districts in Malawi. Two key quantitative measures of feasibility will be used as follows:
- What is the cumulative percentage of eligible index clients offered VAPN services by study end?
- To what extent were the interventions implemented with fidelity? For example, a key measure of the fidelity of the Client Referral VAPN option is to assess what percentage of contacts, who did not return for their scheduled first appointment at the clinic, were subsequently traced according to the specified algorithm (i.e., up to 5 phone calls, and up to 2 home visits)?
- To monitor trends in HIV diagnostic yield from SOC plus VAPN over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Index clients:
- •All index clients who are 18 years old or older (i.e., new positives, known positives not on treatment, and known positives who are on treatment), will be eligible for the study and eligible to receive VAPN services if informed consent is given.
- •Index clients who are inpatients and pregnant women are eligible for inclusion in the study and in VAPN services if informed consent is given.
- •All contacts of any age are eligible to be included in the study and eligible to receive HIV testing services according to Ministry of Health (MOH) guidelines. The age of consent to receive any component of HIV testing services in Malawi is
- •Prior to testing a contact (e.g., a child of an index case) who is <13 years old, for HIV, the guardian's consent is needed, per MOH guidelines.
排除标准
- •Index clients
- •Did not consent
- •Aged <18 years old a
- •Prisoners, Mentally disabled
- •Intimate partner violence
- •Cannot explain the three VAPN options (contract, referral, and dual referral) in a way that would result in true informed assent on the part of the client.
- •There are no exclusion criteria for contacts to be included in the study or receive HIV testing services if they or their guardian desire services. Contacts who are <13 years old will not be contacted by phone under any VAPN contact outreach scenario.
研究组 & 干预措施
Assisted Partner notification services
Voluntary assisted partner notification (VAPN) services will be offered at facilities according to a stepped wedge design. Once VAPN services are activated at a facility, HIV positive individuals will be offered four options (3 voluntary assisted partner notification options and 1 standard of care option) for inviting their contacts, which they can choose to accept or decline.
干预措施: Assisted Partner Notification Services (Other)
结局指标
主要结局
Proportion of eligible index clients offered VAPN services
时间窗: 10 months
Number of eligible index clients who are offered VAPN divide by the number of all eligible index clients identified for enrolment
次要结局
- Proportion of contacts who returned for HIV testing(10 months)
研究者
Hannock Tweya, PhD, MSc
Director of Monitoring, Evaluation and Research
Lighthouse Trust