Evaluation of integration models for HIV and family planning services

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN84228514
• Date of registration: 06/10/2015
• Prospective Registration: No
• Primary sponsor: Population Services International
• Public title: Evaluation of integration models for HIV and family planning services
• Scientific title: Randomized evaluation of HIV and family planning service models
• Date of first enrolment: 17/12/2013
• Target sample size: 3963
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN84228514
• Study type: Interventional
• Study design: Multicentre randomized controlled implementation science research study (Prevention)

Countries of recruitment

Zambia

Contacts

• Name: Paul Hewett

• Name: Mutinta Nalubamba

Key inclusion & exclusion criteria

Inclusion criteria: 1. Presenting at one of the service entry points during the study enrollment period
2. 18 years or older
3. Sexually active, defined as having sex within the past 12 months
4. Plan to reside within the study catchment area for the next 6 months

Exclusion criteria: 1. Unable or unwilling to provide informed consent
2. Unable or unwilling to provide contact information
3. Determined not to be eligible based on the inclusion criteria

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS, STI, family planning and cervical cancer screening services
Urological and Genital Diseases

Intervention(s)

Clients accessing services and voluntarily enrolling were randomized into one of three study arms that offered a different package of services:

1. The standard model of service provision at family planning (FP), HIV testing and counselling (HTC) and voluntary medical male circumcision (VMMC) sites (control)
2. An enhanced client counselling and referral to add-on service arm, with client follow-up
3. An enhanced client add-on service referral and follow-up arm with the addition of an offer of immediate escort to the add-on service

For clients in the two intervention arms, if they did not access the add-on referral services within seven days, they were called and provided additional encouragement and counselling to improve their likelihood of add-on service uptake.

Add-on services consisted of the following:
1. Family planning (FP)
1.1. HIV Testing and Counselling (client/spouse)
1.2. Cervical cancer screening (client)
1.3. VMMC and HTC for (spouses/children)
2. HIV Testing and Counseling (HTC) (client, spouse, children depending on gender)
2.1. HIV care and treatment (for positives) – array of services
2.2. STI care and treatment
2.3. VMMC (for negatives)
2.4. FP
3. Add-on services for Voluntary Male Circumcision (VMMC)
3.1. HIV care and treatment (for positives)
3.2. STI care and treatment
3,.3. HTC (for spouses)
3.4. FP (for spouses)

Study personnel interviewed participants at the study sites at baseline, six weeks, and six months post-enrollment. At the follow-up interviews at six weeks and six months all study participants were asked questions regarding their uptake of an array of add-on services, as well as questions about behaviors and satisfaction with the health services received. Qualitative in-depth interviews conducted among participants and providers from experimental and control sites sought to identify facilitators and barriers to the implementation of enhanced FP and HIV service linkage and integration models. Detailed cost data from entry-poin

Primary Outcome(s)

1. Access to services within 14 days via a client tracking database; client registers at study sites when appearing for add-on service
2. Self-reported uptake of add-on services at six weeks and six months via a structured behavioural interview, such as “in the last six weeks, which of the following services have you accessed at any health facilities..”
3. Costing and client utilization data were gleaned from partner and facility internal records, while client data were collected using identical baseline, six week and six month interview surveys used at control and experimental sites

Secondary Outcome(s)

1. Information regarding the structural and individual barriers to service uptake were obtained through in-depth qualitative interviews with a randomly selected sub-set of participants
2. Client satisfaction with services utilized were obtained at six weeks and six month structured behavioural interview
3. Institutional barriers were obtained through in-depth qualitative interviews conducted at the end of recruitment with clinical providers (nurses, counsellors) who participated in the study

Secondary ID(s)

AID-OAA-A-12-00026

Source(s) of Monetary Support

United States Agency for International Development