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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in South Africa

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:

  1. Rates of testing for HIV,
  2. 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 groups in NCT01953133
Study groupRoleWhat they receive
ControlNo interventionCouples 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 SessionsExperimental4 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.

  1. 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

  2. Sexual Risk Behavior

    Measuring specific sexual risk behaviors including condom use and concurrent partnerships.

    Measured: Up to 9 months post intervention

Secondary outcomes (1)
  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.

  1. First posted30 Sep 2013 (estimated)
  2. Study startApr 2012
  3. Primary completionJun 2015 (estimated)
  4. Study completionJun 2015 (estimated)

Resources

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)
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 18586173
  • Darbes 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

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.

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