Trial · NCT01154296

HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.

NCT01154296, Not applicable, Completed, Columbia University; results first posted 2014-09-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S. Trials, record NCT01154296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01154296

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.
NCT number: NCT01154296
Status: Completed
Phases: Not applicable
Enrollment: 5,012 participants, actual
Lead sponsor: Columbia University
Conditions: HIV/AIDS, Sexually Transmitted Infections
Interventions: RESPECT-2 Counseling
First posted: 2010-06-30
Last updated: 2014-09-29
Results first posted: 2014-09-29

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	STI Incidence	6 months post randomization	Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.
Secondary	Sexual Risk Behavior -- # of Sex Acts	6 months post randomization	Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.
Secondary	Sexual Risk Behavior -- # of Unprotected Sex Acts	6 months post randomization	Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts
Secondary	Sexual Risk Behavior -- # of Partners	6 months post randomization	Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.
Secondary	Sexual Risk Behavior -- # of Unprotected Partners	6 months post randomization	Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.
Secondary	Sexual Risk Behavior -- # of Sex Acts With Substance Use	6 months post randomization	Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	STI Incidence	6 months post randomization	participants	NUMBER
SECONDARY	Sexual Risk Behavior -- # of Sex Acts	6 months post randomization	sex acts	LEAST_SQUARES_MEAN
SECONDARY	Sexual Risk Behavior -- # of Unprotected Sex Acts	6 months post randomization	unprotected sex acts	LEAST_SQUARES_MEAN
SECONDARY	Sexual Risk Behavior -- # of Partners	6 months post randomization	partners	LEAST_SQUARES_MEAN
SECONDARY	Sexual Risk Behavior -- # of Unprotected Partners	6 months post randomization	unprotected partners	LEAST_SQUARES_MEAN
SECONDARY	Sexual Risk Behavior -- # of Sex Acts With Substance Use	6 months post randomization	sex acts with substance use	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
STI Incidence	Rapid HIV Testing w/ Counseling (Group 1)	250		participants
STI Incidence	Rapid HIV Testing & Information Only (Group 2)	226		participants
Sexual Risk Behavior -- # of Sex Acts	Rapid HIV Testing w/ Counseling (Group 1)	28.6	Standard Error 1.1312	sex acts
Sexual Risk Behavior -- # of Sex Acts	Rapid HIV Testing & Information Only (Group 2)	29.1	Standard Error 1.1553	sex acts
Sexual Risk Behavior -- # of Unprotected Sex Acts	Rapid HIV Testing w/ Counseling (Group 1)	17.4	Standard Error 0.9791	unprotected sex acts
Sexual Risk Behavior -- # of Unprotected Sex Acts	Rapid HIV Testing & Information Only (Group 2)	18.3	Standard Error 1.0381	unprotected sex acts
Sexual Risk Behavior -- # of Partners	Rapid HIV Testing w/ Counseling (Group 1)	2.7	Standard Error 0.07454	partners
Sexual Risk Behavior -- # of Partners	Rapid HIV Testing & Information Only (Group 2)	3.0	Standard Error 0.08386	partners
Sexual Risk Behavior -- # of Unprotected Partners	Rapid HIV Testing w/ Counseling (Group 1)	1.1	Standard Error 0.03749	unprotected partners
Sexual Risk Behavior -- # of Unprotected Partners	Rapid HIV Testing & Information Only (Group 2)	1.1	Standard Error 0.03845	unprotected partners

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomization and Intervention	STARTED	Rapid HIV Testing w/ Counseling (Group 1)	2,505
Randomization and Intervention	STARTED	Rapid HIV Testing & Information Only (Group 2)	2,507
Randomization and Intervention	COMPLETED	Rapid HIV Testing w/ Counseling (Group 1)	2,500
Randomization and Intervention	COMPLETED	Rapid HIV Testing & Information Only (Group 2)	2,505
Randomization and Intervention	NOT COMPLETED	Rapid HIV Testing w/ Counseling (Group 1)	5
Randomization and Intervention	NOT COMPLETED	Rapid HIV Testing & Information Only (Group 2)	2
6-month Follow-up	STARTED	Rapid HIV Testing w/ Counseling (Group 1)	2,505
6-month Follow-up	STARTED	Rapid HIV Testing & Information Only (Group 2)	2,507
6-month Follow-up	COMPLETED	Rapid HIV Testing w/ Counseling (Group 1)	2,177
6-month Follow-up	COMPLETED	Rapid HIV Testing & Information Only (Group 2)	2,179

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events10

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
serious	Death, cause unknown	General disorders	Rapid HIV Testing w/ Counseling (Group 1)	1	2,505	1
serious	Death, cause unknown	General disorders	Rapid HIV Testing & Information Only (Group 2)	0	2,507	0
serious	victim of homicide, secondary to robbery	General disorders	Rapid HIV Testing w/ Counseling (Group 1)	1	2,505	1
serious	victim of homicide, secondary to robbery	General disorders	Rapid HIV Testing & Information Only (Group 2)	0	2,507	0
serious	Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Rapid HIV Testing w/ Counseling (Group 1)	1	2,505	1
serious	Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Rapid HIV Testing & Information Only (Group 2)	0	2,507	0
serious	Heart failure	Cardiac disorders	Rapid HIV Testing w/ Counseling (Group 1)	0	2,505	0
serious	Heart failure	Cardiac disorders	Rapid HIV Testing & Information Only (Group 2)	1	2,507	1
serious	Metastatic colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Rapid HIV Testing w/ Counseling (Group 1)	0	2,505	0
serious	Metastatic colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Rapid HIV Testing & Information Only (Group 2)	1	2,507	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rapid HIV Testing w/ Counseling (Group 1)
Total, all-cause mortality	Rapid HIV Testing & Information Only (Group 2)
Total, other adverse events	Rapid HIV Testing w/ Counseling (Group 1)	0	2,505
Total, other adverse events	Rapid HIV Testing & Information Only (Group 2)	0	2,507
Total, serious adverse events	Rapid HIV Testing w/ Counseling (Group 1)	3	2,505
Total, serious adverse events	Rapid HIV Testing & Information Only (Group 2)	2	2,507

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24150466	RESULT	PubMed
26071390	DERIVED	PubMed

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
RC2DA028973	HIV Testing and Counseling in STD Clinics: an Adaptation of CTN 0032	FEASTER, DANIEL J	UNIVERSITY OF MIAMI SCHOOL OF MEDICINE	NATIONAL INSTITUTE ON DRUG ABUSE	2009 to 2010

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Rapid HIV Testing w/ Counseling (Group 1) vs Rapid HIV Testing & Information Only (Group 2): STI Incidence	Trial comparisons
Rapid HIV Testing w/ Counseling (Group 1) vs Rapid HIV Testing & Information Only (Group 2): 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01154296

GET https://conductscience.org/api/trials/v1/NCT01154296/registered

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