HIV InfectionsNCT00503308
HIV Testing Strategies in the Perinatal Setting
A study testing Abbreviated HIV test counseling in people with HIV Infections and Pregnancy Related, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers at San Francisco General Hospital [SFGH]). Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Pregnancy Related
- What is being tested?
- Abbreviated HIV test counseling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Feb 2008
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women 16 years of age or above seeking prenatal care at San Francisco General Hospital
Who cannot join
- Women who do not speak Spanish or English
- Women younger than 16 years of age
- Women who obtained an HIV test during the index pregnancy prior to initiation of prenatal care at SFGH
- Women known to be infected with HIV at initiation of prenatal care at SFGH
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF, San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial
The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers at San Francisco General Hospital [SFGH]).
Read the detailed description
Approximately 40% of HIV-infected infants in the United States in 2000 were born to women not diagnosed with their HIV prior to delivery. (1) There are now effective medical therapies to prevent perinatal transmission, including anti-retroviral therapy, but this requires diagnoses of maternal HIV prior to delivery. Both the Centers for Disease Control and Prevention (CDC) and Institute of Medicine (IOM) have published strong recommendations for universal HIV-antibody testing of pregnant women.
This will be a randomized controlled, non-inferiority trial comparing two HIV testing strategies among English and Spanish-speaking patients presenting for prenatal care at SFGH WHC over the course of approximately one year. Eligible participants will be randomized by study personnel to either standard HIV counseling and testing (control arm) or abbreviated counseling and testing (study arm). Participants will receive a standard prenatal HIV testing brochure, undergo one of two HIV counseling/testing strategies, submit blood for an HIV-1 antibody test, and will follow-up with their medical provider for HIV test results. Upon completion of counseling, participants will undergo a short, structured (Pre-test) questionnaire administered by study staff. Following testing and receipt of results, participants will complete a second (Post-test) structured questionnaire administered by study staff.
Eligible women presenting to SFGH physician or midwife prenatal clinics will be recruited, consented and randomized by study staff to either the standard or abbreviated testing strategy. The outcomes studied will be patient satisfaction and the proportion of study participants who undergo HIV testing. Potential confounder variables to be measured will include demographic characteristics, prior HIV testing history, knowledge about HIV/AIDS, attitudes towards HIV testing, HIV test result, and type of provider (physician versus midwife).
- Conditions
- HIV Infections, Pregnancy Related
- Being tested
- Abbreviated HIV test counseling
- Keywords
- HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated HIV test counselingProcedure or surgery
Also called opt-out HIV testing
abbreviated HIV pre-test counseling
| Study group | Role | What they receive |
|---|---|---|
| Abbreviated Consenting | Experimental | Not described Receives: Procedure: Abbreviated HIV test counseling |
| Standard Consenting | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)
We measured decisional conflict, the primary outcome of the study, using the English or Spanish language 10-item Low Literacy Decisional Conflict Scale. We considered a DCS score of 25 or less to be low, corresponding to limited conflict. All questions have 3 response categories: yes, no, unsure. Items are scored as 0 = yes, 2 = unsure, 4 = no. Scores for each of the 10 items are summed, divided by 2 and multiplied by 25 to calculate the total score. The final scores range from 0(no decisional conflict) to 100 (extremely high decisional conflict).
Measured: same day as HIV test counseling (cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startOct 2006
- Primary completionSep 2007
- Study completionFeb 2008
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 (18)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, San FranciscoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Deborah Cohan, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503308
- Sponsor's protocol ID
- 2004-0319
- Status last verified
- May 2015
- First submitted
- 16 Jul 2007
- Last updated
- 22 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rapid HIV testing of women in labor and delivery: www.cdc.gov/hiv/pubs/rt-women.htm: Centers for Disease Control and Prevention: Divisions of HIV/AIDS Prevention, 2002.
Sambamoorthi U, Akincigil A, McSpiritt E, Crystal S. Zidovudine use during pregnancy among HIV-infected women on Medicaid. J Acquir Immune Defic Syndr. 2002 Aug 1;30(4):429-39. doi: 10.1097/00042560-200208010-00009.
PubMed 12138350Centers for Disease Control and Prevention (CDC). From the Centers for Disease Control and Prevention. Progress toward elimination of perinatal HIV infection--Michigan, 1993-2000. MMWR Morb Mortal Wkly Rep. 2002 Feb 8;51(5):93-7.
PubMed 11892955Kalish LA, Pitt J, Lew J, Landesman S, Diaz C, Hershow R, Hollinger FB, Pagano M, Smeriglio V, Moye J. Defining the time of fetal or perinatal acquisition of human immunodeficiency virus type 1 infection on the basis of age at first positive culture. Women and Infants Transmission Study (WITS). J Infect Dis. 1997 Mar;175(3):712-5. doi: 10.1093/infdis/175.3.712.
PubMed 9041351Newell ML. Mechanisms and timing of mother-to-child transmission of HIV-1. AIDS. 1998 May 28;12(8):831-7. doi: 10.1097/00002030-199808000-00004. No abstract available.
PubMed 9631135Frenkel LM, Cowles MK, Shapiro DE, Melvin AJ, Watts DH, McLellan C, Mohan K, Murante B, Burchett S, Bryson YJ, O'Sullivan MJ, Mitchell C, Landers D. Analysis of the maternal components of the AIDS clinical trial group 076 zidovudine regimen in the prevention of mother-to-infant transmission of human immunodeficiency virus type 1. J Infect Dis. 1997 Apr;175(4):971-4. doi: 10.1086/514003.
PubMed 9086162Shapiro DE, Tuomala R, Samelson R, et al. Mother-to-Child HIV Transmission Rates According to Antiretroviral Therapy, Mode of Delivery, and Viral Load (PACTG 367): Abstract #114. 9th Conference on Retroviruses and Opportunistic Infections. Seattle, WA, 2002.
Phillips KA, Bayer R, Chen JL. New Centers for Disease Control and Prevention's guidelines on HIV counseling and testing for the general population and pregnant women. J Acquir Immune Defic Syndr. 2003 Feb 1;32(2):182-91. doi: 10.1097/00126334-200302010-00010.
PubMed 12571528Centers for Disease Control and Prevention. Revised recommendations for HIV screening of pregnant women. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):63-85; quiz CE1-19a2-CE6-19a2.
PubMed 11718473Centers for Disease Control and Prevention (CDC). HIV testing among pregnant women--United States and Canada, 1998-2001. MMWR Morb Mortal Wkly Rep. 2002 Nov 15;51(45):1013-6.
PubMed 12458916Centers for Disease Control and Prevention (CDC). Advancing HIV prevention: new strategies for a changing epidemic--United States, 2003. MMWR Morb Mortal Wkly Rep. 2003 Apr 18;52(15):329-32.
PubMed 12733863Ruiz JD, Molitor F, Prussing E, Peck L, Grasso P. Prenatal HIV counseling and testing in California: women's experiences and providers' practices. AIDS Educ Prev. 2002 Jun;14(3):190-5. doi: 10.1521/aeap.14.3.190.23896.
PubMed 12092921Simpson WM, Johnstone FD, Goldberg DJ, Gormley SM, Hart GJ. Antenatal HIV testing: assessment of a routine voluntary approach. BMJ. 1999 Jun 19;318(7199):1660-1. doi: 10.1136/bmj.318.7199.1660. No abstract available.
PubMed 10373168Walmsley S. Opt in or opt out: what is optimal for prenatal screening for HIV infection? CMAJ. 2003 Mar 18;168(6):707-8. No abstract available.
PubMed 12642426Stringer EM, Stringer JS, Cliver SP, Goldenberg RL, Goepfert AR. Evaluation of a new testing policy for human immunodeficiency virus to improve screening rates. Obstet Gynecol. 2001 Dec;98(6):1104-8. doi: 10.1016/s0029-7844(01)01631-3.
PubMed 11755561
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT00503308
- Acronym / sponsor ID
- 2004-0319
- Conditions
- HIV Infections, Pregnancy Related
- Keywords
- HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Posted 1 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers at San Francisco General Hospital [SFGH]).
Detailed description
Approximately 40% of HIV-infected infants in the United States in 2000 were born to women not diagnosed with their HIV prior to delivery. (1) There are now effective medical therapies to prevent perinatal transmission, including anti-retroviral therapy, but this requires diagnoses of maternal HIV prior to delivery. Both the Centers for Disease Control and Prevention (CDC) and Institute of Medicine (IOM) have published strong recommendations for universal HIV-antibody testing of pregnant women.
This will be a randomized controlled, non-inferiority trial comparing two HIV testing strategies among English and Spanish-speaking patients presenting for prenatal care at SFGH WHC over the course of approximately one year. Eligible participants will be randomized by study personnel to either standard HIV counseling and testing (control arm) or abbreviated counseling and testing (study arm). Participants will receive a standard prenatal HIV testing brochure, undergo one of two HIV counseling/testing strategies, submit blood for an HIV-1 antibody test, and will follow-up with their medical provider for HIV test results. Upon completion of counseling, participants will undergo a short, structured (Pre-test) questionnaire administered by study staff. Following testing and receipt of results, participants will complete a second (Post-test) structured questionnaire administered by study staff.
Eligible women presenting to SFGH physician or midwife prenatal clinics will be recruited, consented and randomized by study staff to either the standard or abbreviated testing strategy. The outcomes studied will be patient satisfaction and the proportion of study participants who undergo HIV testing. Potential confounder variables to be measured will include demographic characteristics, prior HIV testing history, knowledge about HIV/AIDS, attitudes towards HIV testing, HIV test result, and type of provider (physician versus midwife).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abbreviated Consenting | Experimental | Procedure: Abbreviated HIV test counseling |
| Standard Consenting | No intervention | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women 16 years of age or above seeking prenatal care at San Francisco General Hospital
Key exclusion criteria (4 listed)
- Women who do not speak Spanish or English
- Women younger than 16 years of age
- Women who obtained an HIV test during the index pregnancy prior to initiation of prenatal care at SFGH
- Women known to be infected with HIV at initiation of prenatal care at SFGH
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 |
|---|---|---|
| Abbreviated HIV test counselingAlso: opt-out HIV testingabbreviated HIV pre-test counseling | Procedure or surgery | Abbreviated Consenting |
Primary outcome
Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)
Time frame: same day as HIV test counseling (cross-sectional study)
We measured decisional conflict, the primary outcome of the study, using the English or Spanish language 10-item Low Literacy Decisional Conflict Scale. We considered a DCS score of 25 or less to be low, corresponding to limited conflict. All questions have 3 response categories: yes, no, unsure. Items are scored as 0 = yes, 2 = unsure, 4 = no. Scores for each of the 10 items are summed, divided by 2 and multiplied by 25 to calculate the total score. The final scores range from 0(no decisional conflict) to 100 (extremely high decisional conflict).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundRapid HIV testing of women in labor and delivery: www.cdc.gov/hiv/pubs/rt-women.htm: Centers for Disease Control and Prevention: Divisions of HIV/AIDS Prevention, 2002.
- Background: PubMed 12138350Sambamoorthi U, Akincigil A, McSpiritt E, Crystal S. Zidovudine use during pregnancy among HIV-infected women on Medicaid. J Acquir Immune Defic Syndr. 2002 Aug 1;30(4):429-39. doi: 10.1097/00042560-200208010-00009.
- Background: PubMed 11892955Centers for Disease Control and Prevention (CDC). From the Centers for Disease Control and Prevention. Progress toward elimination of perinatal HIV infection--Michigan, 1993-2000. MMWR Morb Mortal Wkly Rep. 2002 Feb 8;51(5):93-7.
- Background: PubMed 9041351Kalish LA, Pitt J, Lew J, Landesman S, Diaz C, Hershow R, Hollinger FB, Pagano M, Smeriglio V, Moye J. Defining the time of fetal or perinatal acquisition of human immunodeficiency virus type 1 infection on the basis of age at first positive culture. Women and Infants Transmission Study (WITS). J Infect Dis. 1997 Mar;175(3):712-5. doi: 10.1093/infdis/175.3.712.
- Background: PubMed 9631135Newell ML. Mechanisms and timing of mother-to-child transmission of HIV-1. AIDS. 1998 May 28;12(8):831-7. doi: 10.1097/00002030-199808000-00004. No abstract available.
- Background: PubMed 9086162Frenkel LM, Cowles MK, Shapiro DE, Melvin AJ, Watts DH, McLellan C, Mohan K, Murante B, Burchett S, Bryson YJ, O'Sullivan MJ, Mitchell C, Landers D. Analysis of the maternal components of the AIDS clinical trial group 076 zidovudine regimen in the prevention of mother-to-infant transmission of human immunodeficiency virus type 1. J Infect Dis. 1997 Apr;175(4):971-4. doi: 10.1086/514003.
- BackgroundShapiro DE, Tuomala R, Samelson R, et al. Mother-to-Child HIV Transmission Rates According to Antiretroviral Therapy, Mode of Delivery, and Viral Load (PACTG 367): Abstract #114. 9th Conference on Retroviruses and Opportunistic Infections. Seattle, WA, 2002.
- Background: PubMed 12571528Phillips KA, Bayer R, Chen JL. New Centers for Disease Control and Prevention's guidelines on HIV counseling and testing for the general population and pregnant women. J Acquir Immune Defic Syndr. 2003 Feb 1;32(2):182-91. doi: 10.1097/00126334-200302010-00010.
- Background: PubMed 11718473Centers for Disease Control and Prevention. Revised recommendations for HIV screening of pregnant women. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):63-85; quiz CE1-19a2-CE6-19a2.
- Background: PubMed 12458916Centers for Disease Control and Prevention (CDC). HIV testing among pregnant women--United States and Canada, 1998-2001. MMWR Morb Mortal Wkly Rep. 2002 Nov 15;51(45):1013-6.
- Background: PubMed 12733863Centers for Disease Control and Prevention (CDC). Advancing HIV prevention: new strategies for a changing epidemic--United States, 2003. MMWR Morb Mortal Wkly Rep. 2003 Apr 18;52(15):329-32.
- Background: PubMed 12092921Ruiz JD, Molitor F, Prussing E, Peck L, Grasso P. Prenatal HIV counseling and testing in California: women's experiences and providers' practices. AIDS Educ Prev. 2002 Jun;14(3):190-5. doi: 10.1521/aeap.14.3.190.23896.
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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.
Deborah Cohan, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbreviated HIV test counseling in people with HIV Infections and Pregnancy Related, run by University of California, San Francisco at 1 site in United States.
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 1 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 22 May 2015. 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 United States. 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 1 Jul 2011). 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?
Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) (time frame: same day as HIV test counseling (cross-sectional study)). 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 NCT00503308, which also lists 18 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 22 May 2015.