Trial · NCT03135067
Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
NCT03135067, Not applicable, Completed, University of Pennsylvania; results first posted 2022-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk. Trials, record NCT03135067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03135067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
- NCT number
- NCT03135067
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,102 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Provision of multiple self-tests
- First posted
- 2017-05-01
- Last updated
- 2022-12-16
- Results first posted
- 2022-12-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Other | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | HIV Incidence Per 100 Person Years | up to 24 months | cases per 100 person years | NUMBER | |
| SECONDARY | Identification of HIV-positive Male Partners | up to 24 months | partners per participants | MEAN | |
| SECONDARY | 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. | 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. | percentage of participants | NUMBER |
| SECONDARY | 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. | 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. | percentage of participants | NUMBER |
| SECONDARY | 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. | 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. | percentage of participants | NUMBER |
| SECONDARY | 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. | 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. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | 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. | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| HIV Incidence Per 100 Person Years | Provision of Multiple Self-tests | 1.18 | cases per 100 person years | ||
| HIV Incidence Per 100 Person Years | Referral Vouchers for VCT | .98 | cases per 100 person years | ||
| Identification of HIV-positive Male Partners | Provision of Multiple Self-tests | .26 | Standard Deviation 0.71 | partners per participants | |
| Identification of HIV-positive Male Partners | Referral Vouchers for VCT | .13 | Standard Deviation 0.48 | partners per participants | |
| Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | Provision of Multiple Self-tests | 6 months | 11.6 | percentage of participants | |
| Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | Referral Vouchers for VCT | 6 months | 6.2 | percentage of participants | |
| Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | Provision of Multiple Self-tests | 12 months | 7.2 | percentage of participants | |
| Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | Referral Vouchers for VCT | 12 months | 5.2 | percentage of participants | |
| Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | Provision of Multiple Self-tests | 18 months | 5.3 | percentage of participants | |
| Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive | Referral Vouchers for VCT | 18 months | 4.3 | percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Provision of Multiple Self-tests | 1,063 | 33 |
| Overall Study | STARTED | Referral Vouchers for VCT | 1,039 | 33 |
| Overall Study | COMPLETED | Provision of Multiple Self-tests | 1,019 | 33 |
| Overall Study | COMPLETED | Referral Vouchers for VCT | 991 | 33 |
| Overall Study | NOT COMPLETED | Provision of Multiple Self-tests | 44 | 0 |
| Overall Study | NOT COMPLETED | Referral Vouchers for VCT | 48 | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Intimate partner violence and social harms | Social circumstances | Provision of Multiple Self-tests | 241 | 1,017 | |
| other | Intimate partner violence and social harms | Social circumstances | Referral Vouchers for VCT | 210 | 985 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Provision of Multiple Self-tests | 1 | 1,019 |
| Total, all-cause mortality | Referral Vouchers for VCT | 1 | 991 |
| Total, other adverse events | Provision of Multiple Self-tests | 241 | 1,017 |
| Total, other adverse events | Referral Vouchers for VCT | 210 | 985 |
| Total, serious adverse events | Provision of Multiple Self-tests | 0 | 1,019 |
| Total, serious adverse events | Referral Vouchers for VCT | 0 | 991 |
Source ClinicalTrials.gov
Papers37
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH111602 | Secondary distribution of HIV self-tests: an innovative strategy for promoting male partner testing and reducing risk | THIRUMURTHY, HARSHA | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE OF MENTAL HEALTH | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Provision of Multiple Self-tests vs Referral Vouchers for VCT: deaths from any cause | Trial comparisons |
| Provision of Multiple Self-tests vs Referral Vouchers for VCT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03135067
GET https://conductscience.org/api/trials/v1/NCT03135067/results?page=2