HIV/AIDSNCT03215901
Life Plans Intervention Study
A study testing A Beautiful Future Video in people with HIV/AIDS and Chronic HIV Infection, run by Boston University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Chronic HIV Infection, Health Knowledge, Attitudes, Practice
- What is being tested?
- A Beautiful Future Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 1 siteSouth Africa
- Study dates
- 6 Sep 2017to 14 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- <18, >25 years
- not a member of a household under surveillance
- not resident in the surveillance area
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Africa Health Research Institute
Somkhele, KwaZulu-Natal
About this study
Official title: Life Plans of Young Adults in Rural KwaZulu-Natal: an Intervention Study
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.
Read the 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.
- 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.
- 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.
- 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.
- 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.
- Being tested
- A Beautiful Future Video, Active Control Video
- Keywords
- Population-based survey, HIV treatment, HIV testing, Survival expectations, Condom use, Life plans, South African young adults
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Beautiful Future VideoBehavioural
Video delivering information on the longevity gains due to HIV treatment in the area.
Active Control VideoBehavioural
Video on another topic.
| Study group | Role | What they receive |
|---|---|---|
| A Beautiful Future Video | Experimental | Participants randomized to intervention will view intervention video. Receives: Behavioral: A Beautiful Future Video |
| Active Control Video | Sham comparator | Participants randomized to control will watch a video of similar length as the intervention video on a different topic. Receives: Behavioral: Active Control Video |
| Pure Control | No intervention | Participants view no video. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Participated in HIV Testing
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.
Measured: 6 weeks
Secondary outcomes (7)
Use of HIV Testing Voucher
Participants were provided with a voucher for free HIV testing at a local service provider; use of voucher was assessed by obtaining voucher numbers and redemption dates from the service provider.
Measured: 4 weeks
Participation in HIV Testing or Care Services
Same as primary outcome, but also including linkage to clinical HIV services (as assessed by the presence of a CD4 count)
Measured: 3 months
Attendance at Job Search Skills Workshop
At the end of the baseline interview, participants were invited to a job search skills workshop facilitated by a local human resources consultant. Workshops were held at locations convenient to the study area and occurred 1-2 weeks after the baseline survey. Attendance was taken at the workshop. This outcome variable takes the value 1 if the participant attended the workshop and the value 0 if the participant did not attend the workshop.
Measured: 2 weeks
Condoms Purchased
At the end of the baseline survey, participants were offered the opportunity to purchase discount condoms. Participants were given 20 Rand and the opportunity to buy up to 10 condoms for 2 Rand each. The number purchased (0 to 10) was recorded.
Measured: Immediate post-test
Money Allocated to Savings Tin
At the end of the baseline survey, participants were offered the opportunity to allocate a portion of their participation incentive (R100) to a savings tin. The amount saved was recorded. 13.5 Rands = 1 US dollar at the time of study.
Measured: Immediate post-test
Change in Subjective Life Expectancy (Baseline to Immediate Post-test)
Subjective life expectancy was calculated as the under the subjective survival curve. Respondents were asked about the chances of surviving to age 30, 40, ..., 80 years. We linearly interpolated the responses and calculated the area under this curve, which we defined as subjective life expectancy (number of years expected to live between current age and age 80). Subjective life expectancy was elicited at baseline (pre-intervention), baseline (post-intervention), and at 8 weeks. This outcome measure reflects the immediate change in reported survival expectations induced by the intervention.
Measured: Baseline pre-test, Immediate post-test
Subjective Life Expectancy (2 Months)
Subjective life expectancy was calculated as the under the subjective survival curve. Respondents were asked about the chances of surviving to age 30, 40, ..., 80 years. We linearly interpolated the responses and calculated the area under this curve, which we defined as subjective life expectancy (number of years expected to live between current age and age 80). Subjective life expectancy was elicited at baseline (pre-intervention), baseline (post-intervention), and at 8 weeks. This outcome measure reflects the change in reported survival expectations at 8 weeks induced by the intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start6 Sep 2017
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Africa Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Jacob Bor, SD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215901
- Sponsor's protocol ID
- H-36591
- Other IDs
- 5K01MH105320
- Status last verified
- Sep 2018
- First submitted
- 6 Jul 2017
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be archived on the Africa Health Research Institute repository and will be available via a data request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Plans of Young Adults in Rural KwaZulu-Natal: an Intervention Study
- ClinicalTrials.gov ID
- NCT03215901
- Acronym / sponsor ID
- H-36591
- Keywords
- Population-based survey, HIV treatment, HIV testing, Survival expectations, Condom use, Life plans, South African young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Africa Health Research Institute
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Posted 17 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A Beautiful Future Video | Experimental | Behavioral: A Beautiful Future VideoParticipants randomized to intervention will view intervention video. |
| Active Control Video | Sham comparator | Behavioral: Active Control VideoParticipants randomized to control will watch a video of similar length as the intervention video on a different topic. |
| Pure Control | No intervention | –Participants view no video. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- <18, >25 years
- not a member of a household under surveillance
- not resident in the surveillance area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Beautiful Future VideoVideo delivering information on the longevity gains due to HIV treatment in the area. | Behavioural | A Beautiful Future Video |
| Active Control VideoVideo on another topic. | Behavioural | Active Control Video |
Primary outcome
Number of Participants Who Participated in HIV Testing
Time frame: 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.
7 secondary outcomes
Use of HIV Testing Voucher
Time frame: 4 weeks
Participation in HIV Testing or Care Services
Time frame: 3 months
Attendance at Job Search Skills Workshop
Time frame: 2 weeks
Condoms Purchased
Time frame: Immediate post-test
Money Allocated to Savings Tin
Time frame: Immediate post-test
Change in Subjective Life Expectancy (Baseline to Immediate Post-test)
Time frame: Baseline pre-test, Immediate post-test
Subjective Life Expectancy (2 Months)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be archived on the Africa Health Research Institute repository and will be available via a data request.
Related trials for HIV/AIDS
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Bor, SD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Beautiful Future Video in people with HIV/AIDS and Chronic HIV Infection, run by Boston University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Participated in HIV Testing (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.