Human Immunodeficiency Virus
Conditions
Brief summary
The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.
Detailed description
Study Description Brief Summary: The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. Detailed Description: The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. In this study the investigators proposed two phases. The first phase, explained in this submission, is formative and involved two parts: 1) conducting formative qualitative research to understand perceptions of HIV testing and HIV self-testing in the study population and 2) conducting observed HIV self-testing to better understand any challenges with self-testing and the materials needed to make the process clear. The second phase of the study is a randomized controlled trial where the investigators will randomize approximately 400 young women to receive either 1) CHOICE of self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once young women have been randomized, they will be asked to recruit up to 4 peers or male sex partners to test with the method of their randomization group.
Interventions
DIAGNOSTIC_TESTOraquick HIV Self Test - Choice
This is an oral swab in home HIV test.
DIAGNOSTIC_TESTAtomo HIV Self Test - Choice
This is a blood finger prick in home HIV test.
DIAGNOSTIC_TESTOraquick HIV Self Test and Atomo HIV Self Test - Both
This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
Sponsors
University of Witwatersrand, South Africa
University of California, San Francisco
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Qualitative focus group discussions (FGDs) with male and female community members aged 18 - 24 In-clinic observation of HIV self-testing and completion of a brief CAPI/ACASI interview with male and female community members aged 18 - 24
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
FGD Inclusion Criteria: * Females and males aged 18 - 24 * Able and willing to provide informed consent * Residing in the selected villages Observation Inclusion Criteria: * Females and males aged 18 -24 * Able and willing to provide informed consent * Residing in the selected villages * Not known to be HIV positive (not reporting a previous positive test)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Summaries of Participant Experience in Focus Group Discussions | 6 months post study start | Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact |
| Quantitative Summaries of Participants Experience in Observation Sessions | 12 month post study start | Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Focus Group Discussions Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants. | 35 |
| In Clinic Observation-Both 10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test. | 20 |
| In Clinic Observation-Subject Choice 20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test. | 40 |
| Total | 95 |
Baseline characteristics
| Characteristic | In Clinic Observation-Both | In Clinic Observation-Subject Choice | Focus Group Discussions | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 40 Participants | 35 Participants | 95 Participants |
| Age, Continuous | 20 years | 20 years | 20 years | 20 years |
| Region of Enrollment South Africa | 20 Participants | 40 Participants | 35 Participants | 95 Participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 16 Participants | 46 Participants |
| Sex: Female, Male Male | 10 Participants | 20 Participants | 19 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 20 | 0 / 40 |
| serious Total, serious adverse events | 0 / 35 | 0 / 20 | 0 / 40 |
Outcome results
Primary
Qualitative Summaries of Participant Experience in Focus Group Discussions
Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact
Time frame: 6 months post study start
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Focus Group Discussions | Qualitative Summaries of Participant Experience in Focus Group Discussions | HIV Self Test (HST) Acceptability | 100 number of times reported in FGD |
| Focus Group Discussions | Qualitative Summaries of Participant Experience in Focus Group Discussions | HST Context | 7 number of times reported in FGD |
| Focus Group Discussions | Qualitative Summaries of Participant Experience in Focus Group Discussions | HST Kit Preference | 26 number of times reported in FGD |
| Focus Group Discussions | Qualitative Summaries of Participant Experience in Focus Group Discussions | HST motivation | 10 number of times reported in FGD |
| Focus Group Discussions | Qualitative Summaries of Participant Experience in Focus Group Discussions | HST Recommendations | 29 number of times reported in FGD |
| Focus Group Discussions | Qualitative Summaries of Participant Experience in Focus Group Discussions | Supportive resources | 12 number of times reported in FGD |
Primary
Quantitative Summaries of Participants Experience in Observation Sessions
Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results
Time frame: 12 month post study start
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Focus Group Discussions | Quantitative Summaries of Participants Experience in Observation Sessions | Found Instructions Clear | 19 Participants |
| Focus Group Discussions | Quantitative Summaries of Participants Experience in Observation Sessions | Were Very Comfortable Using the Test | 16 Participants |
| Focus Group Discussions | Quantitative Summaries of Participants Experience in Observation Sessions | Very Easy to use the Test | 18 Participants |
| Focus Group Discussions | Quantitative Summaries of Participants Experience in Observation Sessions | Very Easy to Interpret Results | 18 Participants |
| In Clinic Observation - Both (Atomo Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Were Very Comfortable Using the Test | 14 Participants |
| In Clinic Observation - Both (Atomo Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Very Easy to use the Test | 13 Participants |
| In Clinic Observation - Both (Atomo Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Very Easy to Interpret Results | 18 Participants |
| In Clinic Observation - Both (Atomo Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Found Instructions Clear | 19 Participants |
| In Clinic Observation-Subject Choice (Oraquick Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Very Easy to use the Test | 27 Participants |
| In Clinic Observation-Subject Choice (Oraquick Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Were Very Comfortable Using the Test | 24 Participants |
| In Clinic Observation-Subject Choice (Oraquick Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Very Easy to Interpret Results | 31 Participants |
| In Clinic Observation-Subject Choice (Oraquick Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Found Instructions Clear | 30 Participants |
| In Clinic Observation-Subject Choice (Atomo Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Very Easy to Interpret Results | 8 Participants |
| In Clinic Observation-Subject Choice (Atomo Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Were Very Comfortable Using the Test | 6 Participants |
| In Clinic Observation-Subject Choice (Atomo Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Found Instructions Clear | 8 Participants |
| In Clinic Observation-Subject Choice (Atomo Results) | Quantitative Summaries of Participants Experience in Observation Sessions | Very Easy to use the Test | 7 Participants |