Sexually Transmitted InfectionsNCT01242501
Brief HIV Prevention Counseling for STI Patients in South Africa
A study testing 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling. and 20-Min education session in people with Sexually Transmitted Infections, run by University of Connecticut at 1 site in United States.
Trial summary
This is a randomized trial to test a brief single session risk reduction counseling intervention on HIV and STI behavioral outcomes in Cape Town South Africa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexually Transmitted Infections
- What is being tested?
- 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling. and 20-Min education session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- STI clinic patient diagnosed with an STI at current visit
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Randomized Trial of a Brief HIV Risk Reduction Counseling Intervention for Sexually Transmitted Infections Clinic Patients in Cape Town, South Africa
This is a randomized trial to test a brief single session risk reduction counseling intervention on HIV and STI behavioral outcomes in Cape Town South Africa.
Read the detailed description
This 5 year study will conduct a randomized clinical trial of a gender and culturally tailored theory-based behavioral risk reduction intervention for men and women who are receiving sexually transmitted infection (STI) diagnostic and treatment services from STI treatment providers in South Africa. As many as one in five South Africans is HIV positive and there are an estimated 1,500 new HIV infections in South Africa each day. The experimental intervention in this study was developed by South African and US investigators and pilot tested in South Africa. The intervention is grounded in the experience of South African health service provider, empirical research on AIDS-related stigmas, and elements of a social cognitive theory of health behavior change. The intervention consists of a single 60-minute risk reduction counseling session delivered within the context of STI services. Participants will be STI clinic patients over age 18 that have been treated for a previous STI. Participants will be baseline assessed and randomized to receive either (a) the 60 min theory-based and culturally tailored risk reduction intervention or (b) a time and contact matched standard of care HIV and health education session. Participants will be followed for 12 months post intervention. Assessments will be conducted using computer assisted interviews (ACASI). The randomized trial will determine the efficacy of the risk reduction intervention for South African men and women receiving STI clinic services. Outcome analyses will include differences between conditions on new STI diagnoses over 12 months. We will also test the mediating effects of attitudes and beliefs on intervention outcomes. Results of this research will therefore test a clinic-based HIV prevention intervention model that is urgently needed in South Africa.
- Conditions
- Sexually Transmitted Infections
- Being tested
- 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling., 20-Min education session
- Keywords
- Prevention, Counseling, Behavioral interventions, HIV risk reduction
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling.Behavioural
Single session risk reduction counseling delivered in STI clinic settings in South Africa.
20-Min education sessionBehavioural
Patients receive a single 20 min education session for STI/HIV informationSingle brief HIV/STI education only session for men and women receiving sexually transmitted infection clinic services in South Africa. Includes only brief educational information on sexual risks for HIV infection in a single face-to-face counseling session.
| Study group | Role | What they receive |
|---|---|---|
| 60 Min. Risk Reduction Counseling | Experimental | Single 60 min Social Cognitive Theory-based counseling session delivered in STI clinic setting in Cape Town South Africa. Includes educational, motivational, and sexual risk reduction skills components delivered in a single face-to-face counseling session. Receives: Behavioral: 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling. |
| 20-min single session education | Active comparator | Single brief HIV/STI education only session for men and women receiving sexually transmitted infection clinic services in South Africa. Includes only brief educational information on sexual risks for HIV infection in a single face-to-face counseling session. Receives: Behavioral: 20-Min education session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chart abstracted sexually transmitted infections
STI clinic chart abstracted diagnoses over 12 month observation period.
Measured: 12 month aggregate
Secondary outcomes (1)
Sexual behavior change
Computer assisted interview behavioral assessments of sexual risk and risk reduction.
Measured: 3-month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study start1 Aug 2016
- Primary completion15 Jan 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 Group RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth Kalichman, Ph.D., Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242501
- Sponsor's protocol ID
- H05-113
- Status last verified
- Mar 2021
- First submitted
- 15 Nov 2010
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kalichman SC, Cain D, Eaton L, Jooste S, Simbayi LC. Randomized clinical trial of brief risk reduction counseling for sexually transmitted infection clinic patients in Cape Town, South Africa. Am J Public Health. 2011 Sep;101(9):e9-e17. doi: 10.2105/AJPH.2011.300236. Epub 2011 Jul 21.
PubMed 21778486
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Brief HIV Risk Reduction Counseling Intervention for Sexually Transmitted Infections Clinic Patients in Cape Town, South Africa
- ClinicalTrials.gov ID
- NCT01242501
- Acronym / sponsor ID
- H05-113
- Conditions
- Sexually Transmitted Infections
- Keywords
- Prevention, Counseling, Behavioral interventions, HIV risk reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized trial to test a brief single session risk reduction counseling intervention on HIV and STI behavioral outcomes in Cape Town South Africa.
Detailed description
This 5 year study will conduct a randomized clinical trial of a gender and culturally tailored theory-based behavioral risk reduction intervention for men and women who are receiving sexually transmitted infection (STI) diagnostic and treatment services from STI treatment providers in South Africa. As many as one in five South Africans is HIV positive and there are an estimated 1,500 new HIV infections in South Africa each day. The experimental intervention in this study was developed by South African and US investigators and pilot tested in South Africa. The intervention is grounded in the experience of South African health service provider, empirical research on AIDS-related stigmas, and elements of a social cognitive theory of health behavior change. The intervention consists of a single 60-minute risk reduction counseling session delivered within the context of STI services. Participants will be STI clinic patients over age 18 that have been treated for a previous STI. Participants will be baseline assessed and randomized to receive either (a) the 60 min theory-based and culturally tailored risk reduction intervention or (b) a time and contact matched standard of care HIV and health education session. Participants will be followed for 12 months post intervention. Assessments will be conducted using computer assisted interviews (ACASI). The randomized trial will determine the efficacy of the risk reduction intervention for South African men and women receiving STI clinic services. Outcome analyses will include differences between conditions on new STI diagnoses over 12 months. We will also test the mediating effects of attitudes and beliefs on intervention outcomes. Results of this research will therefore test a clinic-based HIV prevention intervention model that is urgently needed in South Africa.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 3 Group RCT
| Arm | Type | Receives |
|---|---|---|
| 60 Min. Risk Reduction Counseling | Experimental | Behavioral: 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling.Single 60 min Social Cognitive Theory-based counseling session delivered in STI clinic setting in Cape Town South Africa. Includes educational, motivational, and sexual risk reduction skills components delivered in a single face-to-face counseling session. |
| 20-min single session education | Active comparator | Behavioral: 20-Min education sessionSingle brief HIV/STI education only session for men and women receiving sexually transmitted infection clinic services in South Africa. Includes only brief educational information on sexual risks for HIV infection in a single face-to-face counseling session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older
- STI clinic patient diagnosed with an STI at current visit
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling.Single session risk reduction counseling delivered in STI clinic settings in South Africa. | Behavioural | 60 Min. Risk Reduction Counseling |
| 20-Min education sessionPatients receive a single 20 min education session for STI/HIV informationSingle brief HIV/STI education only session for men and women receiving sexually transmitted infection clinic services in South Africa. Includes only brief educational information on sexual risks for HIV infection in a single face-to-face counseling session. | Behavioural | 20-min single session education |
Primary outcome
Chart abstracted sexually transmitted infections
Time frame: 12 month aggregate
STI clinic chart abstracted diagnoses over 12 month observation period.
1 secondary outcome
Sexual behavior change
Time frame: 3-month intervals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Results publication: PubMed 21778486Kalichman SC, Cain D, Eaton L, Jooste S, Simbayi LC. Randomized clinical trial of brief risk reduction counseling for sexually transmitted infection clinic patients in Cape Town, South Africa. Am J Public Health. 2011 Sep;101(9):e9-e17. doi: 10.2105/AJPH.2011.300236. Epub 2011 Jul 21.
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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.
Seth Kalichman, Ph.D. principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling. and 20-Min education session in people with Sexually Transmitted Infections, run by University of Connecticut 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 2 inclusion and 1 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 11 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chart abstracted sexually transmitted infections (time frame: 12 month aggregate). 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 NCT01242501, which also lists 1 linked publication.
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 11 Mar 2021.