Trial Outcomes & Findings for Expedited Partner Therapy and the HIV Prevention Cascade (NCT NCT04553211)
NCT ID: NCT04553211
Last Updated: 2026-09-01
Results Overview
Number of participants who self-reported notification of one or more sexual partners at 21-days Follow-up.
COMPLETED
NA
663 participants
21 Days
2026-09-01
Participant Flow
We screened 2,428 individuals and enrolled 556 men who have sex with men diagnosed with gonorrhea and/or chlamydia infection. We also evaluated 112 recent sexual partners of study participants who were diagnosed with gonorrhea and/or chlamydia infection.
No significant events that occurred between the enrollment and assignment of participants to an arm or group.
Participant milestones
| Measure |
Expedited Partner Therapy (EPT)
Participants in the EPT arm received up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Control
Participants in the control arm received standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Expedited Partner Therapy (EPT)-Sexual Partners
Participants diagnosed with gonorrhea and/or chlamydia infection at any study visit were recruited for study participation. We enrolled 20 partners of men in the EPT arm of the trial.
|
Control-Sexual Partners
Participants diagnosed with gonorrhea and/or chlamydia infection at any study visit were recruited for study participation. We enrolled 10 partners of men in the Control arm of the trial.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
279
|
277
|
63
|
44
|
|
Overall Study
COMPLETED
|
222
|
219
|
63
|
44
|
|
Overall Study
NOT COMPLETED
|
57
|
58
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Expedited Partner Therapy and the HIV Prevention Cascade
Baseline characteristics by cohort
| Measure |
Expedited Partner Therapy (EPT)
n=272 Participants
Participants in the EPT arm will receive up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention will be repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Control
n=271 Participants
Participants in the control arm will receive standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling will be repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
272 Participants
n=14 Participants
|
271 Participants
n=36 Participants
|
543 Participants
n=324 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
272 Participants
n=14 Participants
|
271 Participants
n=36 Participants
|
543 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
272 Participants
n=14 Participants
|
271 Participants
n=36 Participants
|
543 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
PRIMARY outcome
Timeframe: 21 DaysNumber of participants who self-reported notification of one or more sexual partners at 21-days Follow-up.
Outcome measures
| Measure |
Expedited Partner Therapy
n=272 Participants
Participants in the EPT arm received up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Control
n=271 Participants
Participants in the control arm received standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
|---|---|---|
|
Number of Participants Who Reported Any Partner Notification
Self-reported notification of one or more recent sexual partner(s)
|
233 Participants
|
189 Participants
|
PRIMARY outcome
Timeframe: 60 DaysPopulation: Partner-confirmed notification
Number of sexual partners who verbally confirmed notification of STI exposure by the index participant
Outcome measures
| Measure |
Expedited Partner Therapy
n=63 Participants
Participants in the EPT arm received up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Control
n=44 Participants
Participants in the control arm received standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
|---|---|---|
|
Number of Partners Who Confirmed Notification
|
20 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 21 DaysPopulation: Number of partners per participant who were reported to have received antibiotic treatment
Number of participants who self-reported that one or more of their sexual partners had received antibiotic treatment at 21-days
Outcome measures
| Measure |
Expedited Partner Therapy
n=272 Participants
Participants in the EPT arm received up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Control
n=271 Participants
Participants in the control arm received standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
|---|---|---|
|
Number of Participants Reporting Any Partner Treatment
|
134 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: 21 DaysPopulation: Number of participants who reported one or more sexual partners received HIV/STI testing
Number of participants who self-reported HIV/STI testing by one or more sexual partners at 21-days
Outcome measures
| Measure |
Expedited Partner Therapy
n=272 Participants
Participants in the EPT arm received up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Control
n=271 Participants
Participants in the control arm received standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
|---|---|---|
|
Number of Participants Reporting Any Partner HIV/STI Testing
|
139 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: 60 DaysPopulation: We were unable to collect sufficient data from recent sexual partners to estimate an effect on partner-confirmed notification. Participants provided name and contact information for only 301 sexual partners at all post-notification evaluations. Of these 301 individuals, counseling staff established contact and verified notification outcomes with 107 partners and scheduled clinical evaluation appointments with 24 individuals, of whom 20 attended the visit.
Number of partners who confirmed receipt of antibiotic treatment following notification of STI exposure by the index participant
Outcome measures
| Measure |
Expedited Partner Therapy
n=63 Participants
Participants in the EPT arm received up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Control
n=44 Participants
Participants in the control arm received standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
|---|---|---|
|
Number of Partners Who Confirmed Treatment
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 60 DaysPopulation: We were unable to collect sufficient data from recent sexual partners to estimate an effect on partner-confirmed notification. Participants provided name and contact information for only 301 sexual partners at all post-notification evaluations. Of these 301 individuals, counseling staff established contact and verified notification outcomes with 42 partners and scheduled clinical evaluation appointments with 24 individuals, of whom 20 attended the visit.
Number of partners who confirmed receiving HIV/STI testing following notification of STI exposure by the index participant
Outcome measures
| Measure |
Expedited Partner Therapy
n=63 Participants
Participants in the EPT arm received up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
Control
n=44 Participants
Participants in the control arm received standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling was repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
|
|---|---|---|
|
Number of Partners Who Confirmed HIV/STI Testing
|
2 Participants
|
4 Participants
|
Adverse Events
Expedited Partner Therapy (EPT)
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place