Clinical trial NCT03215901: Life Plans Intervention Study
Official title: Life Plans of Young Adults in Rural KwaZulu-Natal: an Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Chronic HIV Infection
Health Knowledge, Attitudes, Practice
Keywords: Population-based survey
HIV treatment
HIV testing
Survival expectations
Condom use
Life plans
South African young adults
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Africa Health Research Institute
First posted: 2017-07-12
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

2.c) Re-survey module. Immediately after the video intervention, all study participants will be asked a brief subset of the survey module questions to re-measure survival expectations, locus of control, and life satisfaction. This step will estimate the immediate impact of the video intervention on beliefs.

2.d) Uptake of investment behaviors. 2.d.i) HIV Testing Voucher. Immediately after the re-survey module, participants will be offered a voucher for free HIV testing at a local pharmacy. Redeemed voucher numbers will be collected from the pharmacy to assess uptake of testing. No test results will be collected. This information will be stated clearly on the voucher.

2.d.ii) Invitation to Job Search Skills Workshop. Participants will be invited to a job skills training workshop delivered in partnership with a local human resources consultant. The workshop will inform participants of the types of job opportunities that exist, what skills and qualifications employers are looking for, as well as what strategies can be used to increase chances of getting a job. (For example, recent research in South Africa finds that employers are 60% more likely to respond to job applicants that include a letter of reference.) The workshop will be held at a convenient location 1-3 weeks after the baseline interview and attendance of study participants will be recorded. R10 will be provided to attendees to assist with travel expenses. The goal is to measure differences in uptake across treated and control arms, which will provide short-run evidence of the impact of the video on human capital investment behaviours.

2.d.iii) Savings choice. Immediately after the giving participants the HIV testing voucher, all participants will be offered the opportunity to save a portion of their participation compensation (R100) using a labelled box with a key that we will provide them. We provide this choice for study participants so that we can immediately measure intentions for future-oriented behaviour and to estimate the video's short-term effect based on differences in savings chosen between the treatment and control group.

2.d.iv) Condom offer. Participants will be offered the opportunity to purchase discount condoms and the number purchased will be recorded.

3. Follow-up interview at 2 months. Study participants will be contacted 2 months after their initial interview and provided with a follow-up survey that measures survival expectations, locus of control, and life satisfaction, mental health, savings, health behaviours, and (if applicable) schooling status. Participants will receive R50 in compensation for participation in the follow-up survey.

4. Surveillance Follow-up. Data from this study will be linked at the individual level to the AHRI population surveillance, which contains data on HIV testing, schooling, and employment. Participants will be visited approximately six weeks after the baseline survey and offered HIV testing as part of the AHRI surveillance. Passive follow-up through the surveillance is anticipated in future years, although this is beyond the scope of the registered trial. Linkage will be conducted by AHRI staff with access to identifying information in the population surveillance. After the conclusion of data collection and linkage, the key linking identifying data collected in this study to survey responses will be destroyed and only the de-identified ID number used in the demographic surveillance will remain. Participant contact details (not linked to data) will be retained in order to disseminate findings.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants Who Participated in HIV Testing
timeFrame: 6 weeks
Secondary outcomes:
measure: Use of HIV Testing Voucher
timeFrame: 4 weeks
measure: Participation in HIV Testing or Care Services
timeFrame: 3 months
measure: Attendance at Job Search Skills Workshop
timeFrame: 2 weeks
measure: Condoms Purchased
timeFrame: Immediate post-test
measure: Money Allocated to Savings Tin
timeFrame: Immediate post-test
measure: Change in Subjective Life Expectancy (Baseline to Immediate Post-test)
timeFrame: Baseline pre-test, Immediate post-test
measure: Subjective Life Expectancy (2 Months)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Somkhele
country: South Africa
facility: Africa Health Research Institute
state: KwaZulu-Natal
Study officials:
affiliation: Assistant Professor
name: Jacob Bor, SD
role: PRINCIPAL_INVESTIGATOR
References: