Different approaches to partner notification in primary care

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN24160819
• Date of registration: 18/03/2010
• Prospective Registration: Yes
• Primary sponsor: University of Sussex (UK)
• Public title: Different approaches to partner notification in primary care
• Scientific title: The relative clinical and cost-effectiveness of three contrasting approaches to partner notification for curable sexually transmitted infections (STIs): a cluster randomised trial in primary care
• Date of first enrolment: 01/05/2010
• Target sample size: 3300
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN24160819
• Study type: Interventional
• Study design: Interventional multicentre cluster randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Jackie Cassell

Key inclusion & exclusion criteria

Inclusion criteria: Practices:
1. Practices from the MRC General Practice Research Framework (GPRF), the South East Primary Care Research Network (PCRN-SE) or the Primary Care Research Network Greater London (PCRN-GL)
2. Registered populations of 5000 or more
3. A maximum of six practices considering themselves as "student health centres" will be recruited, and no more than four regarding themselves as running "locally enhanced services for sexual health"

Individuals:
1. Belonging to the target population above
2. Over the age of 16 years (either sex) at the time of first attendance for this problem, or of screening for chlamydia (NB patients will be eligible if they refuse to communicate with partners, given the objectives of the study)
Exclusion criteria: Patients:
1. Learning difficulties
2. Unable to read trial materials after discussion with clinical staff
3. No means of communication acceptable to the patient for him/herself

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Sexually transmitted infections (STIs)
Infections and Infestations
Unspecified sexually transmitted disease

Intervention(s)

We will compare three different interventions in partner treatment:
1. Patient referral: patients are given information about their infection, and asked to tell their partner about the problem and the need to be treated
2. Contract referral: in addition to point 1 above, patients will be asked to agree to a specialist health adviser (contact tracing expert) to inform partner(s) if this has not been done after an agreed period of time (usually two days)
3. Provider referral: in addition to point 1 above, patients will be asked to agree to a specialist health adviser contacting one or more of their partner(s) at the time of diagnosis

Treatment is a communication process without a defined duration. Follow up will be 10 - 12 weeks.

Primary Outcome(s)

1. Number of main partners per index patient treated for chlamydia and/or gonorrhoea/nonspecific urethritis/pelvic inflammatory disease
2. Proportion of index patients testing negative for the relevant STI at 3 months

Secondary Outcome(s)

1. Number of partners per index patient presenting for treatment
2. Proportion of index patients having at least one partner treated
3. Number of main, casual and ex-partners per index patient tested for the relevant STI
4. Number of main, casual and ex-partners testing positive for the relevant STI
5. Number of index patients tested for HIV by 3 months
6. Number of current partners tested for HIV by 3 months
7. Time to definitive treatment of index patient for the relevant STI
8. Time to definitive treatment of current partner for the relevant STI
9. Uptake by index patients of "contract" and "provider" referral for one or more partners, within the relevant randomised groups
10. Patient-related factors impacting on partner notification or STI disclosure to main, casual and ex-partners

An important secondary aim is to identify what patient-related or psychological factors impact on disclosure.

Secondary ID(s)

HTA 07/43/01

Source(s) of Monetary Support

Health Technology Assessment Programme