Trial Outcomes & Findings for Life Plans Intervention Study (NCT NCT03215901)
NCT ID: NCT03215901
Last Updated: 2020-06-17
Results Overview
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.
COMPLETED
NA
430 participants
6 weeks
2020-06-17
Participant Flow
Study participants were recruited from the population surveillance of the Africa Health Research Institute (AHRI) in Somkhele, South Africa, which served as the sampling frame.
From a pre-determined sample of 835 young adults, 433 young adults were found at home and a recruitment attempt was made. Of these, 430 consented to participate. 3 participants dropped out before completing the baseline survey, were not exposed to the treatment, and were blinded to their randomization status. 427 completed the baseline.
Participant milestones
| Measure |
A Beautiful Future Video
Participants randomized to intervention will view intervention video.
A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area.
|
Active Control Video
Participants randomized to control will watch a video of similar length as the intervention video on a different topic.
Active Control Video: Video on another topic.
|
Pure Control
Participants view no video.
|
|---|---|---|---|
|
Overall Study
STARTED
|
199
|
112
|
116
|
|
Overall Study
COMPLETED
|
199
|
112
|
116
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An error in the survey skip pattern led to substantial missing data in the first two weeks of data collection. This was identified during quality control checks, rectified, and enumerators were retrained. 27 of 35 missing values occurred in the first two weeks.
Baseline characteristics by cohort
| Measure |
A Beautiful Future Video
n=199 Participants
Participants randomized to intervention will view intervention video.
A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area.
|
Active Control Video
n=112 Participants
Participants randomized to control will watch a video of similar length as the intervention video on a different topic.
Active Control Video: Video on another topic.
|
Pure Control
n=116 Participants
Participants view no video.
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.7 years
STANDARD_DEVIATION 2.1 • n=199 Participants
|
21.1 years
STANDARD_DEVIATION 2.2 • n=112 Participants
|
20.5 years
STANDARD_DEVIATION 2.1 • n=116 Participants
|
20.8 years
STANDARD_DEVIATION 2.1 • n=427 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=199 Participants
|
63 Participants
n=112 Participants
|
62 Participants
n=116 Participants
|
229 Participants
n=427 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=199 Participants
|
49 Participants
n=112 Participants
|
54 Participants
n=116 Participants
|
198 Participants
n=427 Participants
|
|
Race/Ethnicity, Customized
Zulu-speaking, Black South African
|
199 Participants
n=199 Participants
|
112 Participants
n=112 Participants
|
116 Participants
n=116 Participants
|
427 Participants
n=427 Participants
|
|
Region of Enrollment
South Africa
|
199 participants
n=199 Participants
|
112 participants
n=112 Participants
|
116 participants
n=116 Participants
|
427 participants
n=427 Participants
|
|
Subjective Life Expectancy at Baseline
|
41.0 years
STANDARD_DEVIATION 12.0 • n=181 Participants • An error in the survey skip pattern led to substantial missing data in the first two weeks of data collection. This was identified during quality control checks, rectified, and enumerators were retrained. 27 of 35 missing values occurred in the first two weeks.
|
40.0 years
STANDARD_DEVIATION 11.0 • n=102 Participants • An error in the survey skip pattern led to substantial missing data in the first two weeks of data collection. This was identified during quality control checks, rectified, and enumerators were retrained. 27 of 35 missing values occurred in the first two weeks.
|
39.8 years
STANDARD_DEVIATION 12.0 • n=109 Participants • An error in the survey skip pattern led to substantial missing data in the first two weeks of data collection. This was identified during quality control checks, rectified, and enumerators were retrained. 27 of 35 missing values occurred in the first two weeks.
|
40.4 years
STANDARD_DEVIATION 11.7 • n=392 Participants • An error in the survey skip pattern led to substantial missing data in the first two weeks of data collection. This was identified during quality control checks, rectified, and enumerators were retrained. 27 of 35 missing values occurred in the first two weeks.
|
|
Tested for HIV in Last 12 Months at Baseline
|
116 Participants
n=198 Participants • Totals differ due to item non-response.
|
64 Participants
n=111 Participants • Totals differ due to item non-response.
|
77 Participants
n=115 Participants • Totals differ due to item non-response.
|
257 Participants
n=424 Participants • Totals differ due to item non-response.
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: All participants who completed the baseline survey, n=427.
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.
Outcome measures
| Measure |
A Beautiful Future Video
n=199 Participants
Participants randomized to intervention will view intervention video.
A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area.
|
Active Control Video
n=112 Participants
Participants randomized to control will watch a video of similar length as the intervention video on a different topic.
Active Control Video: Video on another topic.
|
Pure Control
n=116 Participants
Participants view no video.
|
|---|---|---|---|
|
Number of Participants Who Participated in HIV Testing
|
69 Participants
|
33 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: All participants completing the baseline survey, n=427.
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.
Outcome measures
| Measure |
A Beautiful Future Video
n=199 Participants
Participants randomized to intervention will view intervention video.
A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area.
|
Active Control Video
n=112 Participants
Participants randomized to control will watch a video of similar length as the intervention video on a different topic.
Active Control Video: Video on another topic.
|
Pure Control
n=116 Participants
Participants view no video.
|
|---|---|---|---|
|
Use of HIV Testing Voucher
|
20 Participants
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data were not collected.
Same as primary outcome, but also including linkage to clinical HIV services (as assessed by the presence of a CD4 count)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: All participants who completed the baseline survey, n=427.
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.
Outcome measures
| Measure |
A Beautiful Future Video
n=199 Participants
Participants randomized to intervention will view intervention video.
A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area.
|
Active Control Video
n=112 Participants
Participants randomized to control will watch a video of similar length as the intervention video on a different topic.
Active Control Video: Video on another topic.
|
Pure Control
n=116 Participants
Participants view no video.
|
|---|---|---|---|
|
Attendance at Job Search Skills Workshop
|
39 Participants
|
17 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Immediate post-testPopulation: All participants who completed the baseline survey, n=427.
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.
Outcome measures
| Measure |
A Beautiful Future Video
n=199 Participants
Participants randomized to intervention will view intervention video.
A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area.
|
Active Control Video
n=112 Participants
Participants randomized to control will watch a video of similar length as the intervention video on a different topic.
Active Control Video: Video on another topic.
|
Pure Control
n=116 Participants
Participants view no video.
|
|---|---|---|---|
|
Condoms Purchased
|
2.2 condoms purchased
Standard Deviation 2.7
|
2.3 condoms purchased
Standard Deviation 2.3
|
2.4 condoms purchased
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Immediate post-testPopulation: All participants who completed the baseline survey, n=427.
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.
Outcome measures
| Measure |
A Beautiful Future Video
n=199 Participants
Participants randomized to intervention will view intervention video.
A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area.
|
Active Control Video
n=112 Participants
Participants randomized to control will watch a video of similar length as the intervention video on a different topic.
Active Control Video: Video on another topic.
|
Pure Control
n=116 Participants
Participants view no video.
|
|---|---|---|---|
|
Money Allocated to Savings Tin
|
38.6 Rand
Standard Deviation 29.1
|
43.1 Rand
Standard Deviation 28.8
|
39.3 Rand
Standard Deviation 29.4
|
SECONDARY outcome
Timeframe: Baseline pre-test, Immediate post-testPopulation: All participants who completed the baseline survey and had complete data for the survival expectations questions at baseline (pre-intervention) and immediate post-test, n=390.
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.
Outcome measures
| Measure |
A Beautiful Future Video
n=180 Participants
Participants randomized to intervention will view intervention video.
A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area.
|
Active Control Video
n=102 Participants
Participants randomized to control will watch a video of similar length as the intervention video on a different topic.
Active Control Video: Video on another topic.
|
Pure Control
n=108 Participants
Participants view no video.
|
|---|---|---|---|
|
Change in Subjective Life Expectancy (Baseline to Immediate Post-test)
|
1.3 years
Standard Deviation 6.2
|
0.3 years
Standard Deviation 6.4
|
0.7 years
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants with non-missing survival expectations data in the baseline survey and 8-week follow-up survey, n=366.
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.
Outcome measures
| Measure |
A Beautiful Future Video
n=167 Participants
Participants randomized to intervention will view intervention video.
A Beautiful Future Video: Video delivering information on the longevity gains due to HIV treatment in the area.
|
Active Control Video
n=95 Participants
Participants randomized to control will watch a video of similar length as the intervention video on a different topic.
Active Control Video: Video on another topic.
|
Pure Control
n=104 Participants
Participants view no video.
|
|---|---|---|---|
|
Subjective Life Expectancy (2 Months)
|
-0.6 years
Standard Deviation 11.8
|
0.6 years
Standard Deviation 11.4
|
1.0 years
Standard Deviation 11.5
|
Adverse Events
A Beautiful Future Video
Active Control Video
Pure Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place