HIV PreventionNCT01953133
Couples in Context: An RCT of a Couples-based HIV Prevention Intervention
A study testing Couples Counselling Sessions in people with HIV Prevention, run by University of California, San Francisco at 1 site in South Africa.
Trial summary
The prevalence for human immunodeficiency virus (HIV) in South Africa is 18% among 15-49 year old adults and 30% among female antenatal clinic attendees (UNAIDS, 2007), indicating continuing need for effective HIV prevention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Couples Counselling Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2012to Jun 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- both partners 18 or older
- in a relationship with opposite sex partner (defined as: "are you currently in a relationship with a person of the opposite sex to whom you feel committed above anyone else and with whom you have had sexual relations?")
- Both partners report the relationship length has lasted at least 6 months
- Both partners willing and able to provide informed consent
Who cannot join
- Both partners report participating in couples-based testing for HIV with their current partner (Defined as: Both partners tested for HIV at the same time and disclosed results).
- Either partner reports current marital status as polygamous
- Either partner reports domestic violence (as actor or recipient) within the past 6 months with the current partner.
- Both partners have ever disclosed HIV test results to each other via individual or couples testing
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Human Sciences Research Council Sweetwaters
Vilundlela, KwaZulu-Natal
About this study
Official title: Randomized Controlled Trial of a Couples-based Intervention to Increase Testing for HIV Among Heterosexual Couples in Vulindlela, KwaZulu-Natal, South Africa
The prevalence for human immunodeficiency virus (HIV) in South Africa is 18% among 15-49 year old adults and 30% among female antenatal clinic attendees (UNAIDS, 2007), indicating continuing need for effective HIV prevention. Further, recent studies in sub-Saharan Africa found 60-94% of new HIV infections are occurring within marriage or co-habiting heterosexual partnerships (Dunkle et al., 2008). These findings signal the need for HIV prevention interventions that target couples in South Africa. This study is a randomized controlled trial of a behavioral intervention to increase HIV testing among couples living in Vulindlela, South Africa.
The proposed intervention consists of six sessions (one mixed gender group, one single gender group, and four couples' counseling sessions). Using a randomized controlled trial (RCT) design with 350 heterosexual couples, we will test the hypothesis that compared with a one-time mixed-gender group session, the proposed intervention will improve communication, intimacy and trust necessary for mutual decision-making about behaviours related to sexual risk behaviour and testing for HIV. Improving couples' ability and motivation to participate in Couples HIV Testing and Counseling (CHTC) for HIV will in turn lead to reductions in sexual risk behaviour. Both of these outcomes are necessary and effective strategies to reduce the risk of HIV transmission within primary partnerships.
Read more
This intervention is informed by several qualitative studies conducted in Vulindlela and Soweto, South Africa via a K08 award from NIH, as well as other funding sources. These preliminary studies provided insight into the challenges couples face in participating in CHCT, as well as the skills they need in order to address these barriers. Our experience conducting both qualitative and quantitative studies with comparable populations (i.e. South African couples) has also informed the recruitment and retention methods in this intervention. The proposed study takes advantage of the infrastructure and collaborative relationships that the PI has developed that have enabled her to implement and conduct research within these communities.
The specific aims of the project are to test the efficacy of a theory-based and culturally appropriate couples-based intervention on the following outcomes:
- Rates of testing for HIV,
- Sexual risk behaviour for HIV (with primary and any concurrent partners).
In addition we will evaluate the extent to which hypothesized mediating factors (e.g., relationship dynamics) explain the major outcomes and the extent to which the intervention affects these factors.
Ultimately, our goal is to facilitate the outcome that members of partnerships learn their own and their partner's HIV status. This is a crucial step for effective behavioural risk reduction, yet it is a relatively uncommon occurrence for partners in Vulindlela, South Africa. Specifically, mutual disclosure of HIV status accomplishes two important goals.
First, this knowledge can facilitate risk-reduction behaviour within partnerships via effecting positive changes (e.g., condom use) in sexual behaviour with primary and any concurrent partners. Second, knowledge of HIV status can increase access to treatment and care for HIV-positive individuals, as well as reinforce behavioural choices (e.g., limiting concurrent partners) to stay HIV-negative. As couples are particularly vulnerable for HIV infection in this context, increasing testing for HIV and reducing likelihood of behavioural transmission of HIV within partnerships would be a high-impact outcome with the potential to significantly reduce the impact of HIV in an area already severely affected by the pandemic.
- Conditions
- HIV Prevention
- Being tested
- Couples Counselling Sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples Counselling SessionsBehavioural
4 couples' counseling sessions focusing on problem solving and communication skills for the couple. Based upon the Prevention and Relationship Enhancement Program (PREP.)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Couples do not receive intervention (counseling sessions) during study period. They do undergo one group-based session. Upon completion of 9 month follow-up, participants in this arm can undergo a condensed, 2 session version of the intervention. |
| Couples' Counseling Sessions | Experimental | 4 couples' counseling sessions focusing on problem solving and communication skills for the couple. Based upon the Prevention and Relationship Enhancement Program (PREP.) Receives: Behavioral: Couples Counselling Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of testing for HIV
Measuring whether participants underwent Couples HIV Counseling and Testing (CHCT) through the study.
Measured: Up to 9 Months post intervention
Sexual Risk Behavior
Measuring specific sexual risk behaviors including condom use and concurrent partnerships.
Measured: Up to 9 months post intervention
Secondary outcomes (1)
Mediating Factors
The extent to which mediating factors (e.g., relationship dynamics) explain the major outcomes and the extent to which the intervention affects these factors.
Measured: 9 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startApr 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynae Darbes, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953133
- Sponsor's protocol ID
- MH086346
- Status last verified
- Oct 2014
- First submitted
- 24 Sep 2013
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dunkle KL, Stephenson R, Karita E, Chomba E, Kayitenkore K, Vwalika C, Greenberg L, Allen S. New heterosexually transmitted HIV infections in married or cohabiting couples in urban Zambia and Rwanda: an analysis of survey and clinical data. Lancet. 2008 Jun 28;371(9631):2183-91. doi: 10.1016/S0140-6736(08)60953-8.
PubMed 18586173Darbes LA, van Rooyen H, Hosegood V, Ngubane T, Johnson MO, Fritz K, McGrath N. Uthando Lwethu ('our love'): a protocol for a couples-based intervention to increase testing for HIV: a randomized controlled trial in rural KwaZulu-Natal, South Africa. Trials. 2014 Feb 20;15:64. doi: 10.1186/1745-6215-15-64.
PubMed 24552199
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Couples-based Intervention to Increase Testing for HIV Among Heterosexual Couples in Vulindlela, KwaZulu-Natal, South Africa
- ClinicalTrials.gov ID
- NCT01953133
- Acronym / sponsor ID
- MH086346
- Conditions
- HIV Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 30 Sep 2013 (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.
The prevalence for human immunodeficiency virus (HIV) in South Africa is 18% among 15-49 year old adults and 30% among female antenatal clinic attendees (UNAIDS, 2007), indicating continuing need for effective HIV prevention. Further, recent studies in sub-Saharan Africa found 60-94% of new HIV infections are occurring within marriage or co-habiting heterosexual partnerships (Dunkle et al., 2008). These findings signal the need for HIV prevention interventions that target couples in South Africa. This study is a randomized controlled trial of a behavioral intervention to increase HIV testing among couples living in Vulindlela, South Africa.
The proposed intervention consists of six sessions (one mixed gender group, one single gender group, and four couples' counseling sessions). Using a randomized controlled trial (RCT) design with 350 heterosexual couples, we will test the hypothesis that compared with a one-time mixed-gender group session, the proposed intervention will improve communication, intimacy and trust necessary for mutual decision-making about behaviours related to sexual risk behaviour and testing for HIV. Improving couples' ability and motivation to participate in Couples HIV Testing and Counseling (CHTC) for HIV will in turn lead to reductions in sexual risk behaviour. Both of these outcomes are necessary and effective strategies to reduce the risk of HIV transmission within primary partnerships.
This intervention is informed by several qualitative studies conducted in Vulindlela and Soweto, South Africa via a K08 award from NIH, as well as other funding sources. These preliminary studies provided insight into the challenges couples face in participating in CHCT, as well as the skills they need in order to address these barriers. Our experience conducting both qualitative and quantitative studies with comparable populations (i.e. South African couples) has also informed the recruitment and retention methods in this intervention. The proposed study takes advantage of the infrastructure and collaborative relationships that the PI has developed that have enabled her to implement and conduct research within these communities.
The specific aims of the project are to test the efficacy of a theory-based and culturally appropriate couples-based intervention on the following outcomes:
- Rates of testing for HIV,
- Sexual risk behaviour for HIV (with primary and any concurrent partners).
In addition we will evaluate the extent to which hypothesized mediating factors (e.g., relationship dynamics) explain the major outcomes and the extent to which the intervention affects these factors.
Ultimately, our goal is to facilitate the outcome that members of partnerships learn their own and their partner's HIV status. This is a crucial step for effective behavioural risk reduction, yet it is a relatively uncommon occurrence for partners in Vulindlela, South Africa. Specifically, mutual disclosure of HIV status accomplishes two important goals.
First, this knowledge can facilitate risk-reduction behaviour within partnerships via effecting positive changes (e.g., condom use) in sexual behaviour with primary and any concurrent partners. Second, knowledge of HIV status can increase access to treatment and care for HIV-positive individuals, as well as reinforce behavioural choices (e.g., limiting concurrent partners) to stay HIV-negative. As couples are particularly vulnerable for HIV infection in this context, increasing testing for HIV and reducing likelihood of behavioural transmission of HIV within partnerships would be a high-impact outcome with the potential to significantly reduce the impact of HIV in an area already severely affected by the pandemic.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Couples do not receive intervention (counseling sessions) during study period. They do undergo one group-based session. Upon completion of 9 month follow-up, participants in this arm can undergo a condensed, 2 session version of the intervention. |
| Couples' Counseling Sessions | Experimental | Behavioral: Couples Counselling Sessions4 couples' counseling sessions focusing on problem solving and communication skills for the couple. Based upon the Prevention and Relationship Enhancement Program (PREP.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- both partners 18 or older
- in a relationship with opposite sex partner (defined as: "are you currently in a relationship with a person of the opposite sex to whom you feel committed above anyone else and with whom you have had sexual relations?")
- Both partners report the relationship length has lasted at least 6 months
- Both partners willing and able to provide informed consent
Key exclusion criteria (4 listed)
- Both partners report participating in couples-based testing for HIV with their current partner (Defined as: Both partners tested for HIV at the same time and disclosed results).
- Either partner reports current marital status as polygamous
- Either partner reports domestic violence (as actor or recipient) within the past 6 months with the current partner.
- Both partners have ever disclosed HIV test results to each other via individual or couples testing
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 |
|---|---|---|
| Couples Counselling Sessions4 couples' counseling sessions focusing on problem solving and communication skills for the couple. Based upon the Prevention and Relationship Enhancement Program (PREP.) | Behavioural | Couples' Counseling Sessions |
Primary outcome
Rates of testing for HIV
Time frame: Up to 9 Months post intervention
Measuring whether participants underwent Couples HIV Counseling and Testing (CHCT) through the study.
Sexual Risk Behavior
Time frame: Up to 9 months post intervention
Measuring specific sexual risk behaviors including condom use and concurrent partnerships.
1 secondary outcome
Mediating Factors
Time frame: 9 Month Follow Up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
- Background: PubMed 18586173Dunkle KL, Stephenson R, Karita E, Chomba E, Kayitenkore K, Vwalika C, Greenberg L, Allen S. New heterosexually transmitted HIV infections in married or cohabiting couples in urban Zambia and Rwanda: an analysis of survey and clinical data. Lancet. 2008 Jun 28;371(9631):2183-91. doi: 10.1016/S0140-6736(08)60953-8.
- Background: PubMed 24552199Darbes LA, van Rooyen H, Hosegood V, Ngubane T, Johnson MO, Fritz K, McGrath N. Uthando Lwethu ('our love'): a protocol for a couples-based intervention to increase testing for HIV: a randomized controlled trial in rural KwaZulu-Natal, South Africa. Trials. 2014 Feb 20;15:64. doi: 10.1186/1745-6215-15-64.
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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.
Lynae Darbes, PhD 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 Couples Counselling Sessions in people with HIV Prevention, run by University of California, San Francisco at 1 site in South Africa.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Oct 2014. 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 South Africa. 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?
Results are not available in the source record.
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?
Rates of testing for HIV (time frame: Up to 9 Months post intervention). The study lists 2 primary outcomes in all. 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 NCT01953133, which also lists 2 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 Oct 2014.