Human Immunodeficiency VirusNCT03135067
Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
A study testing Provision of multiple self-tests in people with Human Immunodeficiency Virus, run by University of Pennsylvania at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Provision of multiple self-tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,102 participants
- Where
- 1 siteKenya
- Study dates
- 4 Jun 2017to 25 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 exclusion criteria for the men who select to participate.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Provision of multiple self-tests
- Keywords
- HIV self-testing, female sex workers, partner testing, couples testing, transactional sex
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of multiple self-testsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Provision of multiple self-tests |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start4 Jun 2017
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 2,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Impact Research & Development Organization, RTI International, University of North Carolina
- Responsible party
- Sponsor
- Investigators
- Harsha Thirumurthy, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135067
- Sponsor's protocol ID
- 828100
- Other IDs
- R01MH111602
- Status last verified
- Nov 2022
- First submitted
- 17 Apr 2017
- Last updated
- 16 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Unaids, THE GAP REPORT. 2014: Geneva, Switzerland.
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.
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.
PubMed 23966838Sharma 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.
PubMed 26633769Chamie G, Clark TD, Kabami J, Kadede K, Ssemmondo E, Steinfeld R, Lavoy G, Kwarisiima D, Sang N, Jain V, Thirumurthy H, Liegler T, Balzer LB, Petersen ML, Cohen CR, Bukusi EA, Kamya MR, Havlir DV, Charlebois ED. A hybrid mobile approach for population-wide HIV testing in rural east Africa: an observational study. Lancet HIV. 2016 Mar;3(3):e111-9. doi: 10.1016/S2352-3018(15)00251-9. Epub 2016 Jan 26.
PubMed 26939734National AIDS and STI Control Programme (NASCOP), K., Kenya AIDS Indicator Survey 2012: Final Report. 2014, NASCOP: Nairobi.
National AIDS and STI Control Programme, Kenya AIDS Indicator Survey 2012: Nyanza Region Fact Sheet 2014, Nairobi, Kenya: NASCOP.
Ng'ang'a A, Waruiru W, Ngare C, Ssempijja V, Gachuki T, Njoroge I, Oluoch P, Kimanga DO, Maina WK, Mpazanje R, Kim AA; KAIS Study Group. The status of HIV testing and counseling in Kenya: results from a nationally representative population-based survey. J Acquir Immune Defic Syndr. 2014 May 1;66 Suppl 1(Suppl 1):S27-36. doi: 10.1097/QAI.0000000000000102.
PubMed 24732818Baral S, Beyrer C, Muessig K, Poteat T, Wirtz AL, Decker MR, Sherman SG, Kerrigan D. Burden of HIV among female sex workers in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Infect Dis. 2012 Jul;12(7):538-49. doi: 10.1016/S1473-3099(12)70066-X. Epub 2012 Mar 15.
PubMed 22424777WHO, Preventing HIV in Sex Work Settings in sub Saharan Africa. 2011, World Health Organization: Geneva.
Beyrer C, Crago AL, Bekker LG, Butler J, Shannon K, Kerrigan D, Decker MR, Baral SD, Poteat T, Wirtz AL, Weir BW, Barre-Sinoussi F, Kazatchkine M, Sidibe M, Dehne KL, Boily MC, Strathdee SA. An action agenda for HIV and sex workers. Lancet. 2015 Jan 17;385(9964):287-301. doi: 10.1016/S0140-6736(14)60933-8. Epub 2014 Jul 22.
PubMed 25059950Vandenhoudt HM, Langat L, Menten J, Odongo F, Oswago S, Luttah G, Zeh C, Crucitti T, Laserson K, Vulule J, Buve A. Prevalence of HIV and other sexually transmitted infections among female sex workers in Kisumu, Western Kenya, 1997 and 2008. PLoS One. 2013;8(1):e54953. doi: 10.1371/journal.pone.0054953. Epub 2013 Jan 23.
PubMed 23372801Odek WO, Githuka GN, Avery L, Njoroge PK, Kasonde L, Gorgens M, Kimani J, Gelmon L, Gakii G, Isac S, Faran E, Musyoki H, Maina W, Blanchard JF, Moses S. Estimating the size of the female sex worker population in Kenya to inform HIV prevention programming. PLoS One. 2014 Mar 3;9(3):e89180. doi: 10.1371/journal.pone.0089180. eCollection 2014.
PubMed 24595029Kiwanuka N, Ssetaala A, Nalutaaya A, Mpendo J, Wambuzi M, Nanvubya A, Sigirenda S, Kitandwe PK, Nielsen LE, Balyegisawa A, Kaleebu P, Nalusiba J, Sewankambo NK. High incidence of HIV-1 infection in a general population of fishing communities around Lake Victoria, Uganda. PLoS One. 2014 May 27;9(5):e94932. doi: 10.1371/journal.pone.0094932. eCollection 2014.
PubMed 24866840Kwena Z, Mwanzo I, Shisanya C, Camlin C, Turan J, Achiro L, Bukusi E. Predictors of extra-marital partnerships among women married to fishermen along Lake Victoria in Kisumu County, Kenya. PLoS One. 2014 Apr 18;9(4):e95298. doi: 10.1371/journal.pone.0095298. eCollection 2014.
PubMed 24747951
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
- ClinicalTrials.gov ID
- NCT03135067
- Acronym / sponsor ID
- 828100
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV self-testing, female sex workers, partner testing, couples testing, transactional sex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,102 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Impact Research & Development Organization, RTI International, University of North Carolina
- Study start
- 4 Jun 2017 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Posted 16 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Provision of multiple self-tests | Experimental | Behavioral: Provision of multiple self-testsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provision of multiple self-testsParticipants 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. | Behavioural | Provision of multiple self-tests |
Primary outcome
HIV Incidence Per 100 Person Years
Time frame: up to 24 months
HIV incidence over an average follow-up period of 18 months, and up to 24 months, per 100 person years
5 secondary outcomes
Identification of HIV-positive Male Partners
Time frame: 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
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.
Couples Testing With Primary Partner
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.
Primary Partner Tested for HIV
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.
Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundUnaids, THE GAP REPORT. 2014: Geneva, Switzerland.
- BackgroundStaveteig, S., et al., Demographic Patterns of HIV Testing Uptake in Sub-Saharan Africa. DHS Comparative Reports No. 30. Calverton, Maryland, USA: ICF International. 2013.
- Background: PubMed 23966838Suthar 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.
- Background: PubMed 26633769Sharma 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.
- Background: PubMed 26939734Chamie G, Clark TD, Kabami J, Kadede K, Ssemmondo E, Steinfeld R, Lavoy G, Kwarisiima D, Sang N, Jain V, Thirumurthy H, Liegler T, Balzer LB, Petersen ML, Cohen CR, Bukusi EA, Kamya MR, Havlir DV, Charlebois ED. A hybrid mobile approach for population-wide HIV testing in rural east Africa: an observational study. Lancet HIV. 2016 Mar;3(3):e111-9. doi: 10.1016/S2352-3018(15)00251-9. Epub 2016 Jan 26.
- BackgroundNational AIDS and STI Control Programme (NASCOP), K., Kenya AIDS Indicator Survey 2012: Final Report. 2014, NASCOP: Nairobi.
- BackgroundNational AIDS and STI Control Programme, Kenya AIDS Indicator Survey 2012: Nyanza Region Fact Sheet 2014, Nairobi, Kenya: NASCOP.
- Background: PubMed 24732818Ng'ang'a A, Waruiru W, Ngare C, Ssempijja V, Gachuki T, Njoroge I, Oluoch P, Kimanga DO, Maina WK, Mpazanje R, Kim AA; KAIS Study Group. The status of HIV testing and counseling in Kenya: results from a nationally representative population-based survey. J Acquir Immune Defic Syndr. 2014 May 1;66 Suppl 1(Suppl 1):S27-36. doi: 10.1097/QAI.0000000000000102.
- Background: PubMed 22424777Baral S, Beyrer C, Muessig K, Poteat T, Wirtz AL, Decker MR, Sherman SG, Kerrigan D. Burden of HIV among female sex workers in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Infect Dis. 2012 Jul;12(7):538-49. doi: 10.1016/S1473-3099(12)70066-X. Epub 2012 Mar 15.
- BackgroundWHO, Preventing HIV in Sex Work Settings in sub Saharan Africa. 2011, World Health Organization: Geneva.
- Background: PubMed 25059950Beyrer C, Crago AL, Bekker LG, Butler J, Shannon K, Kerrigan D, Decker MR, Baral SD, Poteat T, Wirtz AL, Weir BW, Barre-Sinoussi F, Kazatchkine M, Sidibe M, Dehne KL, Boily MC, Strathdee SA. An action agenda for HIV and sex workers. Lancet. 2015 Jan 17;385(9964):287-301. doi: 10.1016/S0140-6736(14)60933-8. Epub 2014 Jul 22.
- Background: PubMed 23372801Vandenhoudt HM, Langat L, Menten J, Odongo F, Oswago S, Luttah G, Zeh C, Crucitti T, Laserson K, Vulule J, Buve A. Prevalence of HIV and other sexually transmitted infections among female sex workers in Kisumu, Western Kenya, 1997 and 2008. PLoS One. 2013;8(1):e54953. doi: 10.1371/journal.pone.0054953. Epub 2013 Jan 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harsha Thirumurthy, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of multiple self-tests in people with Human Immunodeficiency Virus, run by University of Pennsylvania at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Incidence Per 100 Person Years (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135067, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.