Human Immunodeficiency Virus
Conditions
Brief summary
The Plan and Pledge pilot will incorporate behavioral economics approaches (nudges) into the pre-existing STAR self-test fixed-site distribution program, implemented by Wits Reproductive Health and HIV Institute (Wits RHI) at the University of Witwatersrand, Johannesburg, South Africa. The objective of this pilot is to examine the use of commitment strategies to increase uptake of HIV self-testing in South Africa.
Detailed description
This study will use a cluster randomized trial design to test the effectiveness of interventions designed to increase usage of self-test and reporting of results by HIV self-tests recipients. Specifically, this study will examine the use of commitment and planning prompts to increase the uptake of HIV self-testing in the Tshwane district in South Africa. The intervention will build on the implementation procedures of STAR program (HIV Self-Testing Africa). The two arms in the study will be: 1) Usual care, Promote: A card with information to report results via WhatsApp, similar to the existing card used in the STAR program. with a dedicated Usual care WhatsApp number (different from the existing campaign numbers). 2) Plan and Pledge: A card with the information from the Usual Care card plus a brief template to make a plan and make a pledge for test completion and results reporting, to take the test. The card will include a dedicated Pledge and Plan WhatsApp number. Self-test distribution team-day pair will serve as the unit of randomization (i.e. two pairs of STAR field staff will be randomized by arm and by day. Clusters of individuals will receive self-tests at a distribution site from a pair of STAR field staff on an individual day). Computer-generated randomization will be used to assign site-day clusters to the 2 study arms. The study will take place at the STAR community fixed-point distribution sites in Tshwane District, South Africa.
Interventions
BEHAVIORALProvision 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
BEHAVIORALProvision of HIV self-test
This arm will receive a HIV self-test
Sponsors
Wits Reproductive Health and HIV Institute
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
HIV self-test kits will be distributed at fixed-point distribution sites in the Tshwane district of South Africa and will be grouped into clusters to randomly receive intervention or control. About 44 clusters with an average of 30 participants per cluster, will be selected for the study.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 19 years of age or older
Exclusion criteria
* Intoxication as this effects the result of the HIV self-test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Report of HIV Self-test Result | approximately 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Report of Positive HIV Self-test Result | approximately 3 months | The count of negative:positive test results reported by study arm and compared to the standard of care arm of the STAR program. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Consent for Follow-up | approximately 3 months | The 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. |
| Complete Follow-up | approximately 3 months | The 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 |
| On-site Testing | approximately 3 months | Percent of on-site testers by study arm and compared to the standard of care arm of the STAR program. |
| Confirmatory Testing | approximately 3 months | The percent of self-test recipients who seek confirmatory testing by study arm and compared to the standard of care arm of the STAR program. |
Countries
United States
Participant flow
Pre-assignment details
Field staff were not considered enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| 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 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 | 747 |
| 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 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 | 731 |
| Total | 1,478 |
Baseline characteristics
| Characteristic | Usual Care | Plan and Pledge | Total |
|---|---|---|---|
| Age, Customized Age 18-24 | 395 Participants | 390 Participants | 785 Participants |
| Age, Customized Age 25-39 | 305 Participants | 280 Participants | 585 Participants |
| Age, Customized Age >= 40 | 46 Participants | 57 Participants | 103 Participants |
| Age, Customized Age Not reported | 1 Participants | 4 Participants | 5 Participants |
| Most Recent HIV Test 0-3 Months | 88 Participants | 81 Participants | 169 Participants |
| Most Recent HIV Test 3-12 Months | 372 Participants | 368 Participants | 740 Participants |
| Most Recent HIV Test More than 12 months | 197 Participants | 225 Participants | 422 Participants |
| Most Recent HIV Test Never Tested | 82 Participants | 49 Participants | 131 Participants |
| Most Recent HIV Test Not Reported | 8 Participants | 8 Participants | 16 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Africa | 747 participants | 731 participants | 1478 participants |
| Sex/Gender, Customized Sex/ Gender Female | 398 Participants | 365 Participants | 763 Participants |
| Sex/Gender, Customized Sex/ Gender Male | 348 Participants | 361 Participants | 709 Participants |
| Sex/Gender, Customized Sex/ Gender Transgender/Not Reported | 1 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 747 | 0 / 731 |
| other Total, other adverse events | 0 / 747 | 0 / 731 |
| serious Total, serious adverse events | 0 / 747 | 0 / 731 |
Outcome results
Primary
Report of HIV Self-test Result
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
Time frame: approximately 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Report of HIV Self-test Result | Reported | 59 Participants |
| Usual Care | Report of HIV Self-test Result | Not Reported | 688 Participants |
| Plan and Pledge | Report of HIV Self-test Result | Reported | 63 Participants |
| Plan and Pledge | Report of HIV Self-test Result | Not Reported | 668 Participants |
Secondary
Report of Positive HIV Self-test Result
The count of negative:positive test results reported by study arm and compared to the standard of care arm of the STAR program.
Time frame: approximately 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Report of Positive HIV Self-test Result | Negative | 59 Participants |
| Usual Care | Report of Positive HIV Self-test Result | Positive | 0 Participants |
| Plan and Pledge | Report of Positive HIV Self-test Result | Negative | 63 Participants |
| Plan and Pledge | Report of Positive HIV Self-test Result | Positive | 0 Participants |
Other Pre-specified
Complete Follow-up
The 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
Time frame: approximately 3 months
Other Pre-specified
Confirmatory Testing
The percent of self-test recipients who seek confirmatory testing by study arm and compared to the standard of care arm of the STAR program.
Time frame: approximately 3 months
Other Pre-specified
Consent for Follow-up
The 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.
Time frame: approximately 3 months
Other Pre-specified
On-site Testing
Percent of on-site testers by study arm and compared to the standard of care arm of the STAR program.
Time frame: approximately 3 months