Human Immunodeficiency Virus
Conditions
Keywords
HIV self-testing, female sex workers, partner testing, couples testing, transactional sex
Brief summary
This cluster randomized trial will assess whether the provision of multiple oral-fluid based HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an approach that promotes HIV testing among women's sexual partners, facilitates better sexual decision making, and reduces women's risk of acquiring HIV.
Detailed description
The study will recruit HIV-negative adult women who had two or more sexual partners within the past four weeks in the Nyanza region of Kenya. Beach communities and female sex worker hotspots will be randomized to an intervention group or a control group. In intervention clusters, participants will receive multiple oral fluid-based HIV test kits over a period of up to 24 months, training on how to use the tests, and encouragement to offer tests to current and potential sexual partners with whom sex without condoms is likely. In the comparison clusters, participants will be given referral vouchers for clinic-based HIV testing over a period of up to 24-months and encouraged to distribute these vouchers to sexual partners. Data will be collected from study participants at baseline on demographic and socio-economic characteristics, self-reported sexual behavior, HIV testing history, intimate partner violence history, and mental health outcomes. Follow-up data collection will occur every 6 months. Each month, participants will be sent an invitation to participate in short mobile phone based text message surveys. HIV testing of participants will occur at baseline and at 6 monthly intervals. Based on their reported use of the HIV self-tests, participants will be invited for qualitative interviews to learn more about their interactions with partners with regard to the distribution of self-tests and referral vouchers. Participants will also be given information to distribute to some of their male partners so that those partners can contact study staff to participate in qualitative interviews that will inquired about their perceptions of self-tests. The study has 3 specific aims. Aim 1 will determine the intervention's effect on uptake of HIV testing and identification of HIV infection among participants' sexual partners, self-reported sexual behavior of participants with partners whose HIV status was HIV-positive or not known, and HIV incidence among participants. Aim 2 will use a mixed methods approach to assessing safety and perceptions of the intervention by participants and their sexual partners. Aim 3 will assess the cost-effectiveness of the intervention and obtain information necessary to inform scale-up of the intervention in Kenya and other countries.
Interventions
BEHAVIORALProvision of multiple self-tests
Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.
Sponsors
National Institute of Mental Health (NIMH)
Impact Research & Development Organization
RTI International
University of North Carolina
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Female sex worker hotspots and beach communities in the Nyanza region of Kenya will be grouped into clusters that will be randomly assigned to receive the intervention (provision of multiple HIV self-test kits over time) or control (provision of clinic-based HIV testing referral vouchers over time). About 66 clusters, with an average of 30 participants per cluster, will be selected for the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years old * Currently resides in the study area * Has resided in the study area for at least 6 months in the year prior to enrollment * Intends to stay in the study area for at least 24 months * Reports two or more sexual partners within the past 4 weeks at time of screening * HIV negative * Ownership or access to a mobile phone * Willing and able to provide informed consent
Exclusion criteria
* Younger than 18 years old * Does not currently live in the study area or has not for 6 of the last 12 months, or does not plan to for at least the next 24 months * Fewer than two sexual partners in the last four weeks at time of screening * HIV positive * Has no access to a mobile phone * Enrolled in another HIV prevention study * Cannot or will not provide informed consent * Males will self-select to participate by contacting the study staff using the information provided by willing index participants. There are no inclusion or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Incidence Per 100 Person Years | up to 24 months | HIV incidence over an average follow-up period of 18 months, and up to 24 months, per 100 person years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of HIV-positive Male Partners | up to 24 months | Average number of sexual partners per participant that the participant reported as HIV positive over the course of the study (Total reported positive sexual partners divided by number of participants who completed at least one 6-month follow-up survey); the intent of this measure is to see if participants given HIV self-tests are more likely to identify HIV positive sexual partners. |
| Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months. | Percentage of participants who used a condom with at least one sexual partner after partner refused self-test or HIV testing services referral card, or tested HIV-positive; Note that percentages are rounded to one decimal place. |
| Primary Partner Tested for HIV | Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months. | Percentage of participants who report that their primary partner tested for HIV since enrollment; Note that percentages are rounded to one decimal place. |
| Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months. | Percentage of participants who declined sex with at least one partner after partner refused self-test or HIV testing services referral card, or tested HIV-positive; Note that percentages are rounded to one decimal place. |
| Couples Testing With Primary Partner | Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months. | Percentage of participants who report testing together with their primary partner; Note that percentages are rounded to one decimal place. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intimate Partner Violence (IPV) | Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months. | Percentage of participants in each study group who experience IPV; Note that percentages are rounded to one decimal place. |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Provision of Multiple Self-tests Participants in intervention clusters will be given multiple HIV self-test kits, testing instructions, and advice to use their discretion when offering self-tests to selected sexual partners. Participants will be encouraged to offer self-tests primarily to current and potential partners with whom unprotected sex is likely. All participants will be encouraged to use condoms with sexual partners. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering self-tests to partners. Participants will have opportunities to obtain additional HIV self-test kits on a monthly basis.
Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants. | 1,054 |
| Referral Vouchers for VCT Participants will be given a multiple referral vouchers for HIV testing to distribute to their sexual partners. All participants will be encouraged to use condoms with sexual partners. These referral vouchers will encourage the partners to seek HIV counseling & testing services in local clinics. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering referral vouchers to partners. Participants will have opportunities to obtain additional referral vouchers on a monthly basis. | 1,032 |
| Total | 2,086 |
Baseline characteristics
| Characteristic | Provision of Multiple Self-tests | Total | Referral Vouchers for VCT |
|---|---|---|---|
| Age, Continuous | 26 years | 25 years | 25 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1054 Participants | 2086 Participants | 1032 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 1054 Participants | 2086 Participants | 1032 Participants |
| Sex: Female, Male Female | 1054 Participants | 2086 Participants | 1032 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,019 | 1 / 991 |
| other Total, other adverse events | 241 / 1,017 | 210 / 985 |
| serious Total, serious adverse events | 0 / 1,019 | 0 / 991 |
Outcome results
Primary
HIV Incidence Per 100 Person Years
HIV incidence over an average follow-up period of 18 months, and up to 24 months, per 100 person years
Time frame: up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Provision of Multiple Self-tests | HIV Incidence Per 100 Person Years | 1.18 cases per 100 person years |
| Referral Vouchers for VCT | HIV Incidence Per 100 Person Years | .98 cases per 100 person years |
Secondary
Couples Testing With Primary Partner
Percentage of participants who report testing together with their primary partner; Note that percentages are rounded to one decimal place.
Time frame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
Population: Secondary outcomes were assessed at 6, 12, 18, and 24 month surveys. HIV testing (primary outcome) also occurred at 9, 15, and 21 months, so the number of overall participants may not match what is reported for the primary outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provision of Multiple Self-tests | Couples Testing With Primary Partner | 18 months | 34.7 percentage of participants |
| Provision of Multiple Self-tests | Couples Testing With Primary Partner | 6 months | 80.3 percentage of participants |
| Provision of Multiple Self-tests | Couples Testing With Primary Partner | 24 months | 71.6 percentage of participants |
| Provision of Multiple Self-tests | Couples Testing With Primary Partner | 12 months | 75.3 percentage of participants |
| Referral Vouchers for VCT | Couples Testing With Primary Partner | 24 months | 26.2 percentage of participants |
| Referral Vouchers for VCT | Couples Testing With Primary Partner | 12 months | 34.7 percentage of participants |
| Referral Vouchers for VCT | Couples Testing With Primary Partner | 18 months | 26.7 percentage of participants |
| Referral Vouchers for VCT | Couples Testing With Primary Partner | 6 months | 32.9 percentage of participants |
Secondary
Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive
Percentage of participants who declined sex with at least one partner after partner refused self-test or HIV testing services referral card, or tested HIV-positive; Note that percentages are rounded to one decimal place.
Time frame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
Population: Secondary outcomes were assessed at 6, 12, 18, and 24 month surveys. HIV testing (primary outcome) also occurred at 9, 15, and 21 months, so the number of overall participants may not match what is reported for the primary outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provision of Multiple Self-tests | Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 6 months | 14.2 percentage of participants |
| Provision of Multiple Self-tests | Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 12 months | 5.1 percentage of participants |
| Provision of Multiple Self-tests | Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 18 months | 4.5 percentage of participants |
| Provision of Multiple Self-tests | Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 24 months | 2.3 percentage of participants |
| Referral Vouchers for VCT | Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 24 months | 3 percentage of participants |
| Referral Vouchers for VCT | Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 6 months | 7.1 percentage of participants |
| Referral Vouchers for VCT | Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 18 months | 3.8 percentage of participants |
| Referral Vouchers for VCT | Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 12 months | 6 percentage of participants |
Secondary
Identification of HIV-positive Male Partners
Average number of sexual partners per participant that the participant reported as HIV positive over the course of the study (Total reported positive sexual partners divided by number of participants who completed at least one 6-month follow-up survey); the intent of this measure is to see if participants given HIV self-tests are more likely to identify HIV positive sexual partners.
Time frame: up to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Provision of Multiple Self-tests | Identification of HIV-positive Male Partners | .26 partners per participants | Standard Deviation 0.71 |
| Referral Vouchers for VCT | Identification of HIV-positive Male Partners | .13 partners per participants | Standard Deviation 0.48 |
Secondary
Primary Partner Tested for HIV
Percentage of participants who report that their primary partner tested for HIV since enrollment; Note that percentages are rounded to one decimal place.
Time frame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
Population: Secondary outcomes were assessed at 6, 12, 18, and 24 month surveys. HIV testing (primary outcome) also occurred at 9, 15, and 21 months, so the number of overall participants may not match what is reported for the primary outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provision of Multiple Self-tests | Primary Partner Tested for HIV | 6 months | 87.5 percentage of participants |
| Provision of Multiple Self-tests | Primary Partner Tested for HIV | 12 months | 81.2 percentage of participants |
| Provision of Multiple Self-tests | Primary Partner Tested for HIV | 18 months | 77.8 percentage of participants |
| Provision of Multiple Self-tests | Primary Partner Tested for HIV | 24 months | 74.9 percentage of participants |
| Referral Vouchers for VCT | Primary Partner Tested for HIV | 24 months | 39 percentage of participants |
| Referral Vouchers for VCT | Primary Partner Tested for HIV | 6 months | 48.3 percentage of participants |
| Referral Vouchers for VCT | Primary Partner Tested for HIV | 18 months | 39.8 percentage of participants |
| Referral Vouchers for VCT | Primary Partner Tested for HIV | 12 months | 48.6 percentage of participants |
Secondary
Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive
Percentage of participants who used a condom with at least one sexual partner after partner refused self-test or HIV testing services referral card, or tested HIV-positive; Note that percentages are rounded to one decimal place.
Time frame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
Population: Secondary outcomes were assessed at 6, 12, 18, and 24 month surveys. HIV testing (primary outcome) also occurred at 9, 15, and 21 months, so the number of overall participants may not match what is reported for the primary outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provision of Multiple Self-tests | Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 6 months | 11.6 percentage of participants |
| Provision of Multiple Self-tests | Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 12 months | 7.2 percentage of participants |
| Provision of Multiple Self-tests | Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 18 months | 5.3 percentage of participants |
| Provision of Multiple Self-tests | Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 24 months | 3.3 percentage of participants |
| Referral Vouchers for VCT | Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 24 months | 4.9 percentage of participants |
| Referral Vouchers for VCT | Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 6 months | 6.2 percentage of participants |
| Referral Vouchers for VCT | Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 18 months | 4.3 percentage of participants |
| Referral Vouchers for VCT | Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | 12 months | 5.2 percentage of participants |
Other Pre-specified
Intimate Partner Violence (IPV)
Percentage of participants in each study group who experience IPV; Note that percentages are rounded to one decimal place.
Time frame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
Population: Secondary outcomes were assessed at 6, 12, 18, and 24 month surveys. HIV testing (primary outcome) also occurred at 9, 15, and 21 months, so the number of overall participants may not match what is reported for the primary outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provision of Multiple Self-tests | Intimate Partner Violence (IPV) | 6 months | 17.3 percentage of participants |
| Provision of Multiple Self-tests | Intimate Partner Violence (IPV) | 12 months | 10.8 percentage of participants |
| Provision of Multiple Self-tests | Intimate Partner Violence (IPV) | 18 months | 6.1 percentage of participants |
| Provision of Multiple Self-tests | Intimate Partner Violence (IPV) | 24 months | 5.0 percentage of participants |
| Referral Vouchers for VCT | Intimate Partner Violence (IPV) | 24 months | 5.2 percentage of participants |
| Referral Vouchers for VCT | Intimate Partner Violence (IPV) | 6 months | 16.4 percentage of participants |
| Referral Vouchers for VCT | Intimate Partner Violence (IPV) | 18 months | 3.5 percentage of participants |
| Referral Vouchers for VCT | Intimate Partner Violence (IPV) | 12 months | 17.7 percentage of participants |