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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH111602 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Impact Research & Development Organization | OTHER |
| RTI International | OTHER |
| University of North Carolina |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provision of multiple self-tests | Experimental | 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. |
|
| Referral vouchers for VCT | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provision of multiple self-tests | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intimate Partner Violence (IPV) | Percentage of participants in each study group who experience IPV; Note that percentages are rounded to one decimal place. | 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. |
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Harsha Thirumurthy, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Impact Research and Development Organization | Kisumu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Unaids, THE GAP REPORT. 2014: Geneva, Switzerland. | ||
| Background | Staveteig, S., et al., Demographic Patterns of HIV Testing Uptake in Sub-Saharan Africa. DHS Comparative Reports No. 30. Calverton, Maryland, USA: ICF International. 2013. | ||
| 23966838 | Background | Suthar AB, Ford N, Bachanas PJ, Wong VJ, Rajan JS, Saltzman AK, Ajose O, Fakoya AO, Granich RM, Negussie EK, Baggaley RC. Towards universal voluntary HIV testing and counselling: a systematic review and meta-analysis of community-based approaches. PLoS Med. 2013 Aug;10(8):e1001496. doi: 10.1371/journal.pmed.1001496. Epub 2013 Aug 13. | |
| 26633769 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants at baseline differs from the number of participants in the participant flow: 10 participants were duplicates, thus removed from the study after enrollment; 2 were found to be ineligible after enrollment; 4 participant baseline surveys were lost.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | cases per 100 person years | up to 24 months |
|
Adverse events were monitored and recorded for the full 24 month duration of the study (June 4, 2017 - March 25, 2020).
Other (Not Including Serious) Adverse Events for this study was categorized as Intimate partner violence (IPV) and social harms. IPV was only assessed via 6-month surveys, so the denominators vary from other AE categories.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intimate partner violence and social harms | Social circumstances | Non-systematic Assessment | Individuals who reported ever experiencing intimate partner violence (IPV) while participating in the study, that may or may not have been related to study participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harsha Thirumurthy | University of Pennsylvania | 215-746-0410 | hthirumu@upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2018 | Jan 24, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| OTHER |
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.
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|
| up to 24 months |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Background |
| Sharma M, Ying R, Tarr G, Barnabas R. Systematic review and meta-analysis of community and facility-based HIV testing to address linkage to care gaps in sub-Saharan Africa. Nature. 2015 Dec 3;528(7580):S77-85. doi: 10.1038/nature16044. |
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| Background | National AIDS and STI Control Programme (NASCOP), K., Kenya AIDS Indicator Survey 2012: Final Report. 2014, NASCOP: Nairobi. |
| Background | National AIDS and STI Control Programme, Kenya AIDS Indicator Survey 2012: Nyanza Region Fact Sheet 2014, Nairobi, Kenya: NASCOP. |
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| Background | Thirumurthy, H., et al. Acceptability and feasibility of a novel approach to promote HIV testing in sexual and social networks using HIV self-tests. . in International AIDS Society (IAS) conference. 2015. Vancouver, Canada. |
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| Background | National AIDS and STD Control Programme, Guidelines for HIV Testing and Counselling in Kenya, Ministry of Public Health and Sanitation Kenya, Editor. 2008, Nairobi: NASCOP. |
| Background | National AIDS and STI Control Programme, Guidelines for HIV Testing Services in Kenya. 2015, Nairobi: National AIDS Control Programme. |
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| Background | Orasure Techonologies, I., OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Package Insert. Accessed 14 September 2011 http://www.orasure.com/products-infectious/products-infectious-oraquick.asp: Bethlehem, PA. |
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| 35770697 | Derived | Ruderman LW, Ochwal P, Marcus N, Napierala S, Thirumurthy H, Agot K, Maman S. 'When I have these kits ... I have confidence' - HIV self-testing provides agency for women in their sexual decision-making. Glob Public Health. 2022 Dec;17(12):3735-3746. doi: 10.1080/17441692.2022.2092176. Epub 2022 Jun 30. |
| 34856179 | Derived | Thirumurthy H, Bair EF, Ochwal P, Marcus N, Putt M, Maman S, Napierala S, Agot K. The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial. Lancet HIV. 2021 Dec;8(12):e736-e746. doi: 10.1016/S2352-3018(21)00248-4. |
| 32589354 | Derived | Napierala S, Bair EF, Marcus N, Ochwal P, Maman S, Agot K, Thirumurthy H. Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial. J Int AIDS Soc. 2020 Jun;23 Suppl 2(Suppl 2):e25515. doi: 10.1002/jia2.25515. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | partners per participants | up to 24 months |
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|
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| 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. | 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. | Posted | Number | percentage of participants | 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. |
|
|
|
| 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. | 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. | Posted | Number | percentage of participants | 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. |
|
|
|
| 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. | 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. | Posted | Number | percentage of participants | 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. |
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| 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. | 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. | Posted | Number | percentage of participants | 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. |
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| 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. | 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. | Posted | Number | percentage of participants | 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. |
|
|
|
| 1 |
| 1,019 |
| 0 |
| 1,019 |
| 241 |
| 1,017 |
| EG001 | 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 | 991 | 0 | 991 | 210 | 985 |
|
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| 12 months |
|
|
| 18 months |
|
|
| 24 months |
|
|
| 12 months |
|
|
| 18 months |
|
|
| 24 months |
|
|
| 12 months |
|
|
| 18 months |
|
|
| 24 months |
|
|
| 12 months |
|
|
| 18 months |
|
|
| 24 months |
|
|
| 12 months |
|
|
| 18 months |
|
|
| 24 months |
|
|