Trial Outcomes & Findings for Plan and Pledge, HIV Self-testing in South Africa (NCT NCT03898557)
NCT ID: NCT03898557
Last Updated: 2024-06-26
Results Overview
The percent of self-test recipients who report self-test result on the dedicated WhatsApp number and are HIV positive, by study arm and compared to the standard of care arm of the STAR program
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1479 participants
Primary outcome timeframe
approximately 3 months
Results posted on
2024-06-26
Participant Flow
Field staff were not considered enrolled in this study.
Participant milestones
| Measure |
Usual Care
Participants randomized to this arm will receive a card with information to report results via WhatsApp, similar to the existing card used in the STAR program. This card will have a dedicated Usual Care WhatsApp number (different from the existing STAR program numbers).
Potential self-test recipients will be shown the WhatsApp card and instructed on how to anonymously report use of self-test to the WhatsApp number. Recipients (participants) will be instructed to message the WhatsApp number for the following reasons:
1\. To message study staff, so they know that self-test recipients(participants) used the test and it went ok. 2. So study staff can help the self-test recipients (participants) understand the results of the test. 3. If the self-test recipients (participants) need support from study staff to access care and services.
Provision of HIV self-test: This arm will receive a HIV self-test
|
Plan and Pledge
Participants randomized to this arm will revive the Usual Care WhatsApp card and and a brief template to "make a plan" and "make a pledge" for test completion and results reporting, to take the HIV self-test. The card will include a dedicated Plan and Pledge WhatsApp number.
Potential self-tester recipients (participants) will be shown the WhatsApp card, including Plan and Pledge statements, and will be encouraged by STAR field staff to use the card in their own time to make a plan and sign the pledge as part of receiving the test kit and instructions for how to complete the card. Importantly, testers will be able to keep the card for themselves. There is no expectation to share the plan or the pledge signature with the STAR field staff who distribute self-tests. Field staff will clarify for self-tests recipients (participants) that the Plan and Pledge process and card do not change the confidentiality of testing in any way.
Provision of HIV self-test with Commitment and planning prompts: The interventions will use behavioral interventions such as commitment and planning prompts to increase the update of HIV self-testing
|
|---|---|---|
|
Overall Study
STARTED
|
747
|
731
|
|
Overall Study
COMPLETED
|
747
|
731
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Usual Care
n=747 Participants
Participants randomized to this arm will receive a card with information to report results via WhatsApp, similar to the existing card used in the STAR program. This card will have a dedicated Usual Care WhatsApp number (different from the existing STAR program numbers).
Potential self-test recipients will be shown the WhatsApp card and instructed on how to anonymously report use of self-test to the WhatsApp number. Recipients will be instructed to message the WhatsApp number for the following reasons:
1\. So study staff know the self-test recipients used the test and it went ok. 2. So study staff can help the self-test recipients understand the results of the test. 3. If the self-test recipients need support from study staff to access care and services.
Provision of HIV self-test: This arm will receive a HIV self-test
|
Plan and Pledge
n=731 Participants
Participants randomized to this arm will revive the Usual Care WhatsApp card and and a brief template to "make a plan" and "make a pledge" for test completion and results reporting, to take the HIV self-test. The card will include a dedicated Plan and Pledge WhatsApp number.
Potential self-tester recipients will be shown the WhatsApp card, including Plan and Pledge statements, and will be encouraged by STAR field staff to use the card in their own time to make a plan and sign the pledge as part of receiving the test kit and instructions for how to complete the card. Importantly, testers will be able to keep the card for themselves. There is no expectation to share the plan or the pledge signature with the STAR field staff who distribute self-tests. Field staff will clarify for self-tests recipients that the Plan and Pledge process and card do not change the confidentiality of testing in any way.
Provision of HIV self-test with Commitment and planning prompts: The interventions will use behavioral interventions such as commitment and planning prompts to increase the update of HIV self-testing
|
Total
n=1478 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 18-24
|
395 Participants
n=747 Participants
|
390 Participants
n=731 Participants
|
785 Participants
n=1478 Participants
|
|
Age, Customized
Age · 25-39
|
305 Participants
n=747 Participants
|
280 Participants
n=731 Participants
|
585 Participants
n=1478 Participants
|
|
Age, Customized
Age · >= 40
|
46 Participants
n=747 Participants
|
57 Participants
n=731 Participants
|
103 Participants
n=1478 Participants
|
|
Age, Customized
Age · Not reported
|
1 Participants
n=747 Participants
|
4 Participants
n=731 Participants
|
5 Participants
n=1478 Participants
|
|
Sex/Gender, Customized
Sex/ Gender · Female
|
398 Participants
n=747 Participants
|
365 Participants
n=731 Participants
|
763 Participants
n=1478 Participants
|
|
Sex/Gender, Customized
Sex/ Gender · Male
|
348 Participants
n=747 Participants
|
361 Participants
n=731 Participants
|
709 Participants
n=1478 Participants
|
|
Sex/Gender, Customized
Sex/ Gender · Transgender/Not Reported
|
1 Participants
n=747 Participants
|
5 Participants
n=731 Participants
|
6 Participants
n=1478 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
747 participants
n=747 Participants
|
731 participants
n=731 Participants
|
1478 participants
n=1478 Participants
|
|
Most Recent HIV Test
Never Tested
|
82 Participants
n=747 Participants
|
49 Participants
n=731 Participants
|
131 Participants
n=1478 Participants
|
|
Most Recent HIV Test
0-3 Months
|
88 Participants
n=747 Participants
|
81 Participants
n=731 Participants
|
169 Participants
n=1478 Participants
|
|
Most Recent HIV Test
3-12 Months
|
372 Participants
n=747 Participants
|
368 Participants
n=731 Participants
|
740 Participants
n=1478 Participants
|
|
Most Recent HIV Test
More than 12 months
|
197 Participants
n=747 Participants
|
225 Participants
n=731 Participants
|
422 Participants
n=1478 Participants
|
|
Most Recent HIV Test
Not Reported
|
8 Participants
n=747 Participants
|
8 Participants
n=731 Participants
|
16 Participants
n=1478 Participants
|
PRIMARY outcome
Timeframe: approximately 3 monthsThe percent of self-test recipients who report self-test result on the dedicated WhatsApp number and are HIV positive, by study arm and compared to the standard of care arm of the STAR program
Outcome measures
| Measure |
Usual Care
n=747 Participants
Participants randomized to this arm will receive a card with information to report results via WhatsApp, similar to the existing card used in the STAR program. This card will have a dedicated Usual Care WhatsApp number (different from the existing STAR program numbers).
Potential self-test recipients will be shown the WhatsApp card and instructed on how to anonymously report use of self-test to the WhatsApp number. Recipients will be instructed to message the WhatsApp number for the following reasons:
1\. So study staff know the self-test recipients used the test and it went ok. 2. So study staff can help the self-test recipients understand the results of the test. 3. If the self-test recipients need support from study staff to access care and services.
Provision of HIV self-test: This arm will receive a HIV self-test
|
Plan and Pledge
n=731 Participants
Participants randomized to this arm will revive the Usual Care WhatsApp card and and a brief template to "make a plan" and "make a pledge" for test completion and results reporting, to take the HIV self-test. The card will include a dedicated Plan and Pledge WhatsApp number.
Potential self-tester recipients will be shown the WhatsApp card, including Plan and Pledge statements, and will be encouraged by STAR field staff to use the card in their own time to make a plan and sign the pledge as part of receiving the test kit and instructions for how to complete the card. Importantly, testers will be able to keep the card for themselves. There is no expectation to share the plan or the pledge signature with the STAR field staff who distribute self-tests. Field staff will clarify for self-tests recipients that the Plan and Pledge process and card do not change the confidentiality of testing in any way.
Provision of HIV self-test with Commitment and planning prompts: The interventions will use behavioral interventions such as commitment and planning prompts to increase the update of HIV self-testing
|
|---|---|---|
|
Report of HIV Self-test Result
Reported
|
59 Participants
|
63 Participants
|
|
Report of HIV Self-test Result
Not Reported
|
688 Participants
|
668 Participants
|
SECONDARY outcome
Timeframe: approximately 3 monthsThe count of negative:positive test results reported by study arm and compared to the standard of care arm of the STAR program.
Outcome measures
| Measure |
Usual Care
n=59 Participants
Participants randomized to this arm will receive a card with information to report results via WhatsApp, similar to the existing card used in the STAR program. This card will have a dedicated Usual Care WhatsApp number (different from the existing STAR program numbers).
Potential self-test recipients will be shown the WhatsApp card and instructed on how to anonymously report use of self-test to the WhatsApp number. Recipients will be instructed to message the WhatsApp number for the following reasons:
1\. So study staff know the self-test recipients used the test and it went ok. 2. So study staff can help the self-test recipients understand the results of the test. 3. If the self-test recipients need support from study staff to access care and services.
Provision of HIV self-test: This arm will receive a HIV self-test
|
Plan and Pledge
n=63 Participants
Participants randomized to this arm will revive the Usual Care WhatsApp card and and a brief template to "make a plan" and "make a pledge" for test completion and results reporting, to take the HIV self-test. The card will include a dedicated Plan and Pledge WhatsApp number.
Potential self-tester recipients will be shown the WhatsApp card, including Plan and Pledge statements, and will be encouraged by STAR field staff to use the card in their own time to make a plan and sign the pledge as part of receiving the test kit and instructions for how to complete the card. Importantly, testers will be able to keep the card for themselves. There is no expectation to share the plan or the pledge signature with the STAR field staff who distribute self-tests. Field staff will clarify for self-tests recipients that the Plan and Pledge process and card do not change the confidentiality of testing in any way.
Provision of HIV self-test with Commitment and planning prompts: The interventions will use behavioral interventions such as commitment and planning prompts to increase the update of HIV self-testing
|
|---|---|---|
|
Report of Positive HIV Self-test Result
Negative
|
59 Participants
|
63 Participants
|
|
Report of Positive HIV Self-test Result
Positive
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 3 monthsThe percent of self-test recipients who consent to phone/SMS follow-up by study arm and compared to the standard of care arm of the STAR program.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 3 monthsThe percent of self-test recipients who are successfully reached for follow-up by phone about 7 days after receiving the HIV self-test, by study arm and compared to the standard of care arm of the STAR program
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 3 monthsPercent of on-site testers by study arm and compared to the standard of care arm of the STAR program.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approximately 3 monthsThe percent of self-test recipients who seek confirmatory testing by study arm and compared to the standard of care arm of the STAR program.
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Plan and Pledge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alison M. Buttenheim, PhD MBA
University of Pennsylvania
Phone: 215.573.5314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place