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临床试验/NCT03215901
NCT03215901已完成不适用

Life Plans of Young Adults in Rural KwaZulu-Natal: an Intervention Study

Boston University1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2017年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
430
试验地点
1
主要终点
Number of Participants Who Participated in HIV Testing

研究概览

简要总结

The mass provision of HIV treatment in rural KwaZulu-Natal, South Africa has raised adult life expectancy by 18 years since 2003. We will conduct a population-based survey to assess young adults' beliefs about HIV, HIV treatment, and expectations for the future in the era of mass HIV treatment. Thh investigators will conduct a randomized evaluation to assess whether a short video providing young adults with information on longevity gains from HIV treatment affects young adults survival expectations, hope for the future, and health and educational behaviours, including uptake of HIV testing, the study's primary outcome.

详细描述

The proposed study will investigate survival expectations and health behaviours among young adults ages 18 to 25. Potential respondents will be sampled at random from a population listing from the demographic and health surveillance system of the Africa Health Research Institute (AHRI) in Somkhele, South Africa. Potential participants will be visited at home to be recruited for the study.

  1. Consent. The study will be described and participants will provide written informed consent to participate in the study, including the baseline visit, a follow-up survey, and permission to link with demographic surveillance data.
  2. Baseline interview (1.5 hours)

2.a) Survey module. First, a survey questionnaire will be conducted with young adults ages 18 to 25 to learn about their survival expectations, perceptions of HIV risks and treatment, future-oriented behaviours such as smoking, alcohol use, HIV risk behaviors, savings, locus of control, mental health, time and risk preference, and life satisfaction.

2.b) Video intervention. After the survey module, study participants will be randomized into treatment and control groups. Both interview participants and interviewers will be blinded to treatment assignment prior to this stage. The treatment group will be shown a 10 minute video that provides information on the changes in HIV-related mortality and life expectancy in the Demographic Surveillance Area between 2003 and today (an increase of about 18 years in the average length of life). The video includes testimonials from community members who have lived long and fulfilling lives on HIV treatment. The goal of the video is to increase measured survival expectations, hope, locus of control, and future orientation. The control group will receive a 10-minute video clip on another topic. Participants will be asked briefly for an open-ended response to the video: "what did the video make you think about?" which will be transcribed or recorded.

Details on randomization procedures: treatment assignment will be determined at the level of the household, such that if there are multiple respondents per household, they receive the same treatment. Households will be randomized to the intervention video or control ex ante. Though treatment assignment will occur ex ante, it will only be revealed - to both the field workers and the respondents - after completing the initial survey module. Ex ante randomization has two benefits. First, as a quality control, ex ante randomization limits the opportunity for violations of treatment assignment. Second, it increases power by enabling stratification on baseline variables. Because the study is nested in the AHRI population surveillance, treated and control households can be balanced on household size, wealth, and other characteristics. Treated and controls will be randomized at a 1:1 ratio, with controls further sub-randomized 1:1 to attention-placebo vs. pure control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • resides in Africa Health Research Institute demographic surveillance area, specifically bounded structures to be visited during the last trimester of the surveillance in the "Southern PIPSA" area.
  • member of a household in the AHRI demographic surveillance
  • 18 to 25 years of age

排除标准

  • <18, >25 years
  • not a member of a household under surveillance
  • not resident in the surveillance area

结局指标

主要结局

Number of Participants Who Participated in HIV Testing

时间窗: 6 weeks

Participants were provided a voucher at baseline for free HIV testing at a private pharmacy in the area. This voucher could be used at any time within four weeks after baseline. Participants were also visited by an AHRI demographic and health surveillance team approximately six weeks after baseline during which all household members were offered a home-based rapid HIV test. This outcome takes the value of 1 if the participant used the HIV testing voucher OR participated in HIV testing during the household surveillance visit, and zero if the participant did not use the HIV testing voucher AND did not participate in HIV testing during the household surveillance visit.

次要结局

  • Money Allocated to Savings Tin(Immediate post-test)
  • Subjective Life Expectancy (2 Months)(8 weeks)
  • Use of HIV Testing Voucher(4 weeks)
  • Participation in HIV Testing or Care Services(3 months)
  • Condoms Purchased(Immediate post-test)
  • Attendance at Job Search Skills Workshop(2 weeks)
  • Change in Subjective Life Expectancy (Baseline to Immediate Post-test)(Baseline pre-test, Immediate post-test)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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