HIV InfectionsNCT03271307
Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
A study testing Optimized PITC, Facility HIVST and Index HIVST in people with HIV Infections, run by University of California, Los Angeles at 1 site in Malawi.
Trial summary
This study comprises two trials to evaluate the feasibility and cost-effectiveness of HIV self-testing strategies compared to standard of care among clients in outpatient departments (OPD; Aim 1) and the sexual partners of HIV-positive clients (index testing; Aim 2). Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Optimized PITC, Facility HIVST and Index HIVST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,369 participants
- Where
- 1 siteMalawi
- Study dates
- 25 Sep 2017to 25 Jan 2019
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 15 years or older
- Willing and able to provide informed consent
- Being seen for OPD services at the time of the study (Aim 1)
- HIV-positive (Aim 2)
- Have at least one sex partner in the catchment area with an unknown HIV status at the time of study enrollment (Aim 2)
Who cannot join
- Currently enrolled in the INTERVAL study
- Guardians attending clinics with OPD clients (Aim 1)
- History of intimate partner violence in the past 12 months (Aim 2)
- Fear of intimate partner violence as a consequence of participating in the study (Aim 2)
Trial locations and contacts
1 site in 1 country.
About this study
This study comprises two trials to evaluate the feasibility and cost-effectiveness of HIV self-testing strategies compared to standard of care among clients in outpatient departments (OPD; Aim 1) and the sexual partners of HIV-positive clients (index testing; Aim 2).
Aim 1 will be a cluster-randomized trial in 15 clusters (high-burden health facilities) in Malawi. We will enroll 6,000 adult OPD clients (15 years or older) to test the feasibility and cost-effectiveness of facility-based HIV self-testing (HIVST) for OPD clients.
Aim 2 will be an individually-randomized trial in 3 high-burden health facilities in Malawi. We will enroll 500 adult HIV-positive clients (15 years or older) to test the feasibility and cost-effectiveness of index HIVST among partners of HIV-positive clients.
Read the detailed description
The study includes two unblinded trials to evaluate the feasibility and cost-effectiveness of HIVST strategies among adults in Malawi.
Aim 1 will test the feasibility and cost-effectiveness of facility-based HIVST in OPD sites in Malawi. It will be an unblinded cluster-randomized trial and include three arms: 1) standard of care for provider-initiated testing and counseling (PITC); (2) optimized standard of care for PITC; and (3) facility-based HIVST while clients wait for routine OPD services. The standard of care arm will receive no intervention. The optimized standard of care arm will receive training and support for implementing the Malawi guidelines for PITC and morning testing. OPD clients in the facility HIVST arm will receive a HIVST demonstration and distribution, followed by uses of HIVST and private spaces for kit interpretation before receiving routine OPD services. Participants may present their self-test results to their provider, who will refer them for confirmatory HIV testing and routine ART initiation (if positive). That same day, participants from all arms will complete a brief survey upon exiting the clinic. Survey and medical record data will be compared across arms to determine whether facility HIVST is superior in regard to number of individuals tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive.
Aim 2 will test the feasibility and cost-effectiveness of index HIVST for the sexual partners of HIV-positive clients. It will be an unblinded individually-randomized trial and include two arms: 1) standard of care partner referral slips for testing; and 2) HIVST. The standard of care arm will receive no intervention for partner notification and referral. HIV-positive clients in the HIVST arm will receive a HIVST demonstration and distribution, with instructions to give the HIVST kit to their sexual partner. Participants will be given one HIVST for each of their sexual partners who has an unknown HIV status or who tested HIV-negative more than six months prior (up to 3 HIVST kits distributed). Participants (index clients) will be given instructions on how their partner can complete the self-test and how to refer their partner(s) to care if they receive a positive result from the self-test. All participants (standard of care and HIVST arms) will complete a brief survey at the beginning of the intervention and a 4-week follow-up survey to assess primary and secondary outcomes. Medical chart reviews will be conducted for all partners reported to test HIV-positive in order to assess ART initiation rates. Survey and medical record data will be compared across arms to determine whether index HIVST is superior in regard to number of partners tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive.
- Conditions
- HIV Infections
- Being tested
- Optimized PITC, Facility HIVST, Index HIVST
- Keywords
- self-test, testing, cost-effectiveness
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized PITCBehavioural
Also called Optimized standard of care
Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.
Facility HIVSTDiagnostic test
HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.
Index HIVSTDiagnostic test
HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| AIm 1: Standard of care | No intervention | Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility. |
| Aim 1: Optimized standard of care | Experimental | Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1. Receives: Behavioral: Optimized PITC |
| Aim 1: Facility HIVST | Experimental | Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC). Receives: Diagnostic Test: Facility HIVST |
| Aim 2: Standard of care | No intervention | Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing. |
| Aim 2: Index HIVST | Experimental | Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips). Receives: Diagnostic Test: Index HIVST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Proportion of Adult OPD Clients Tested for HIV
Same day HIV testing among OPD clients, measured by self-reports from OPD clients
Measured: 1 day
Aim 2: Proportion of Sexual Partners Tested for HIV
HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients
Measured: 4-weeks
Secondary outcomes (9)
Aim 1: HIV-positivity Rate
HIV-positivity rate among OPD clients, measured by self-report
Measured: Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)
Aim 1: ART Initiation Among OPD Clients Tested HIV-positive
ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts
Measured: 3 months
Aim 1: Presence of Non-serious Adverse Events
Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, and unwanted status disclosure, measured by self-report on the day the intervention was delivered.
Measured: as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)
Aim 1: Cost Per Person Initiated ART
Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.
Measured: 3 months
Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV
HIV-positivity rate measured by secondary report by the HIV-positive client
Measured: 4-weeks
Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive
ART initiation within 3-months after being identified as HIV-positive within the study, measured by medical chart reviews of all Partners in Hope supported health facilities in participating districts
Measured: 3 months
Aim 2: Presence of Non-serious Adverse Events
Presence of adverse events due to the HIV testing intervention, including coercion to test, share test results, unwanted status disclosure, and interpersonal violence measured by self-report by the HIV-positive client
Measured: 4-weeks
Aim 2: Cost Per Person Tested HIV-Positive
Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual tested HIV-positive by each arm, respectively. All costs in 2017 US$. Cost calculations include all costs associated with HIV testing. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per HIV-positive individual identified. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.
Measured: 1 month
Aim 2: Cost Per Person Initiated ART
Total cost per arm (including human resources, testing, training, equipment, facility over head, staff, and testing supplies) / total number of individual initiated ART by each arm, respectively. All costs in 2017 US$. Cost calculations do not include cost of ART. Cost data in each study group were derived from a health care perspective using micro-costing methods using the HIV Counselling and Testing costing tool developed by the Health Economics and Epidemiology Research Office in South Africa. All costs are reported in 2017 US$. We use mean cost per ART initiate. Standard deviation is not included due to the nature of calculating a 'production cost'- or the total cost incurred per the respective number of outcomes.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start25 Sep 2017
- Primary completion13 Jun 2018
- Study completion25 Jan 2019
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 (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include two arms and methodology: (Aim 1) A cluster-randomized trial comparing HIV testing strategies for OPD clients, clustered by health facility; and (Aim 2) A individual-randomized trial comparing HIV testing strategies for partners of HIV-positive clients.
- Masking
- None (open label)
- Enrolment
- 6,369 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Partners in Hope, Inc., United States Agency for International Development (USAID), Right to Care, Ministry of Health, Malawi
- Responsible party
- Principal investigator, Kathryn L. Dovel, PhD, University of California, Los Angeles
- Investigators
- Kathryn Dovel, PhD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271307
- Sponsor's protocol ID
- 17-000109
- Status last verified
- Nov 2020
- First submitted
- 31 Aug 2017
- Last updated
- 2 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dovel K, Balakasi K, Phiri K, Shaba F, Offorjebe OA, Gupta SK, Wong V, Lungu E, Nichols BE, Masina T, Worku A, Hoffman R, Nyirenda M. Effect of index HIV self-testing for sexual partners of clients enrolled in antiretroviral therapy (ART) programs in Malawi: A randomized controlled trial. PLoS Med. 2023 Aug 4;20(8):e1004270. doi: 10.1371/journal.pmed.1004270. eCollection 2023 Aug.
PubMed 37540649Mphande M, Campbell P, Hoffman RM, Phiri K, Nyirenda M, Gupta SK, Wong V, Dovel K. Barriers and facilitators to facility HIV self-testing in outpatient settings in Malawi: a qualitative study. BMC Public Health. 2021 Dec 2;21(1):2200. doi: 10.1186/s12889-021-12213-6.
PubMed 34856958Dovel K, Shaba F, Offorjebe OA, Balakasi K, Nyirenda M, Phiri K, Gupta SK, Wong V, Tseng CH, Nichols BE, Cele R, Lungu E, Masina T, Coates TJ, Hoffman RM. Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial. Lancet Glob Health. 2020 Feb;8(2):e276-e287. doi: 10.1016/S2214-109X(19)30534-0.
PubMed 31981557Dovel K, Shaba F, Nyirenda M, Offorjebe OA, Balakasi K, Phiri K, Nichols B, Tseng CH, Bardon A, Ngona K, Hoffman R. Evaluating the integration of HIV self-testing into low-resource health systems: study protocol for a cluster-randomized control trial from EQUIP Innovations. Trials. 2018 Sep 17;19(1):498. doi: 10.1186/s13063-018-2878-y.
PubMed 30223874
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
- ClinicalTrials.gov ID
- NCT03271307
- Acronym / sponsor ID
- 17-000109
- Conditions
- HIV Infections
- Keywords
- self-test, testing, cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,369 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Partners in Hope, Inc., United States Agency for International Development (USAID), Right to Care, Ministry of Health, Malawi
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Posted 2 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study comprises two trials to evaluate the feasibility and cost-effectiveness of HIV self-testing strategies compared to standard of care among clients in outpatient departments (OPD; Aim 1) and the sexual partners of HIV-positive clients (index testing; Aim 2).
Aim 1 will be a cluster-randomized trial in 15 clusters (high-burden health facilities) in Malawi. We will enroll 6,000 adult OPD clients (15 years or older) to test the feasibility and cost-effectiveness of facility-based HIV self-testing (HIVST) for OPD clients.
Aim 2 will be an individually-randomized trial in 3 high-burden health facilities in Malawi. We will enroll 500 adult HIV-positive clients (15 years or older) to test the feasibility and cost-effectiveness of index HIVST among partners of HIV-positive clients.
Detailed description
The study includes two unblinded trials to evaluate the feasibility and cost-effectiveness of HIVST strategies among adults in Malawi.
Aim 1 will test the feasibility and cost-effectiveness of facility-based HIVST in OPD sites in Malawi. It will be an unblinded cluster-randomized trial and include three arms: 1) standard of care for provider-initiated testing and counseling (PITC); (2) optimized standard of care for PITC; and (3) facility-based HIVST while clients wait for routine OPD services. The standard of care arm will receive no intervention. The optimized standard of care arm will receive training and support for implementing the Malawi guidelines for PITC and morning testing. OPD clients in the facility HIVST arm will receive a HIVST demonstration and distribution, followed by uses of HIVST and private spaces for kit interpretation before receiving routine OPD services. Participants may present their self-test results to their provider, who will refer them for confirmatory HIV testing and routine ART initiation (if positive). That same day, participants from all arms will complete a brief survey upon exiting the clinic. Survey and medical record data will be compared across arms to determine whether facility HIVST is superior in regard to number of individuals tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive.
Aim 2 will test the feasibility and cost-effectiveness of index HIVST for the sexual partners of HIV-positive clients. It will be an unblinded individually-randomized trial and include two arms: 1) standard of care partner referral slips for testing; and 2) HIVST. The standard of care arm will receive no intervention for partner notification and referral. HIV-positive clients in the HIVST arm will receive a HIVST demonstration and distribution, with instructions to give the HIVST kit to their sexual partner. Participants will be given one HIVST for each of their sexual partners who has an unknown HIV status or who tested HIV-negative more than six months prior (up to 3 HIVST kits distributed). Participants (index clients) will be given instructions on how their partner can complete the self-test and how to refer their partner(s) to care if they receive a positive result from the self-test. All participants (standard of care and HIVST arms) will complete a brief survey at the beginning of the intervention and a 4-week follow-up survey to assess primary and secondary outcomes. Medical chart reviews will be conducted for all partners reported to test HIV-positive in order to assess ART initiation rates. Survey and medical record data will be compared across arms to determine whether index HIVST is superior in regard to number of partners tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study will include two arms and methodology: (Aim 1) A cluster-randomized trial comparing HIV testing strategies for OPD clients, clustered by health facility; and (Aim 2) A individual-randomized trial comparing HIV testing strategies for partners of HIV-positive clients.
| Arm | Type | Receives |
|---|---|---|
| AIm 1: Standard of care | No intervention | –Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility. |
| Aim 1: Optimized standard of care | Experimental | Behavioral: Optimized PITCFacilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1. |
| Aim 1: Facility HIVST | Experimental | Diagnostic Test: Facility HIVSTFacilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC). |
| Aim 2: Standard of care | No intervention | –Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing. |
| Aim 2: Index HIVST | Experimental | Diagnostic Test: Index HIVSTFacilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 15 years or older
- Willing and able to provide informed consent
- Being seen for OPD services at the time of the study (Aim 1)
- HIV-positive (Aim 2)
- Have at least one sex partner in the catchment area with an unknown HIV status at the time of study enrollment (Aim 2)
Key exclusion criteria (4 listed)
- Currently enrolled in the INTERVAL study
- Guardians attending clinics with OPD clients (Aim 1)
- History of intimate partner violence in the past 12 months (Aim 2)
- Fear of intimate partner violence as a consequence of participating in the study (Aim 2)
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 |
|---|---|---|
| Optimized PITCAlso: Optimized standard of careProviders will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation. | Behavioural | Aim 1: Optimized standard of care |
| Facility HIVSTHIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted. | Diagnostic test | Aim 1: Facility HIVST |
| Index HIVSTHIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted. | Diagnostic test | Aim 2: Index HIVST |
Primary outcome
Aim 1: Proportion of Adult OPD Clients Tested for HIV
Time frame: 1 day
Same day HIV testing among OPD clients, measured by self-reports from OPD clients
Aim 2: Proportion of Sexual Partners Tested for HIV
Time frame: 4-weeks
HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients
9 secondary outcomes
Aim 1: HIV-positivity Rate
Time frame: Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)
Aim 1: ART Initiation Among OPD Clients Tested HIV-positive
Time frame: 3 months
Aim 1: Presence of Non-serious Adverse Events
Time frame: as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)
Aim 1: Cost Per Person Initiated ART
Time frame: 3 months
Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV
Time frame: 4-weeks
Aim 2: ART Initiation Among Sexual Partners Tested HIV-positive
Time frame: 3 months
Aim 2: Presence of Non-serious Adverse Events
Time frame: 4-weeks
Aim 2: Cost Per Person Tested HIV-Positive
Time frame: 1 month
Aim 2: Cost Per Person Initiated ART
Time frame: 3 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37540649Dovel K, Balakasi K, Phiri K, Shaba F, Offorjebe OA, Gupta SK, Wong V, Lungu E, Nichols BE, Masina T, Worku A, Hoffman R, Nyirenda M. Effect of index HIV self-testing for sexual partners of clients enrolled in antiretroviral therapy (ART) programs in Malawi: A randomized controlled trial. PLoS Med. 2023 Aug 4;20(8):e1004270. doi: 10.1371/journal.pmed.1004270. eCollection 2023 Aug.
- Derived from this study: PubMed 34856958Mphande M, Campbell P, Hoffman RM, Phiri K, Nyirenda M, Gupta SK, Wong V, Dovel K. Barriers and facilitators to facility HIV self-testing in outpatient settings in Malawi: a qualitative study. BMC Public Health. 2021 Dec 2;21(1):2200. doi: 10.1186/s12889-021-12213-6.
- Derived from this study: PubMed 31981557Dovel K, Shaba F, Offorjebe OA, Balakasi K, Nyirenda M, Phiri K, Gupta SK, Wong V, Tseng CH, Nichols BE, Cele R, Lungu E, Masina T, Coates TJ, Hoffman RM. Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial. Lancet Glob Health. 2020 Feb;8(2):e276-e287. doi: 10.1016/S2214-109X(19)30534-0.
- Derived from this study: PubMed 30223874Dovel K, Shaba F, Nyirenda M, Offorjebe OA, Balakasi K, Phiri K, Nichols B, Tseng CH, Bardon A, Ngona K, Hoffman R. Evaluating the integration of HIV self-testing into low-resource health systems: study protocol for a cluster-randomized control trial from EQUIP Innovations. Trials. 2018 Sep 17;19(1):498. doi: 10.1186/s13063-018-2878-y.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Kathryn Dovel, PhD, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized PITC, Facility HIVST and Index HIVST in people with HIV Infections, run by University of California, Los Angeles at 1 site in Malawi.
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 5 inclusion and 4 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 2 Dec 2020. 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 Malawi. 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 2 Dec 2020). 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?
Aim 1: Proportion of Adult OPD Clients Tested for HIV (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT03271307, which also lists 4 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 2 Dec 2020.