Randomised evaluation of the One Community programme in Malawi

• Register: ISRCTN
• Last refreshed on: 3 April 2017
• Main ID: ISRCTN42438149
• Date of registration: 03/03/2017
• Prospective Registration: Yes
• Primary sponsor: Population Council
• Public title: Randomised evaluation of the One Community programme in Malawi
• Scientific title: Stepped-wedge cluster randomised evaluation of the impact of the One Community programme on the wellbeing and HIV prevention behaviours of orphans and vulnerable children, adolescent girls and young women and other vulnerable populations in Southern Malawi
• Date of first enrolment: 06/03/2017
• Target sample size: 2070
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN42438149
• Study type: Observational
• Study design: Multi-centre cluster stepped-wedge randomised evaluation repeat cross-sectional observational study (Prevention)

Countries of recruitment

Malawi

Contacts

• Name: Paul C. Hewett

Key inclusion & exclusion criteria

Inclusion criteria: Orphans and vulnerable children (OVC) caregivers:
1. Be identified as a household with one or more OVC children from the household screening
2. Serving as a main caregiver or guardian for an OVC child in their household
3. Must be 18 years of age or older
4. Willing and able to provide informed consent to participate

Adolescent girls and young women (AGYW) :
1. Be identified as a household with one or more out-of-school AGYW from the household screening
2. Must be 15–24 years of age and not currently attending school
3. Randomly selected if there is more than one out-of-school AGYW in the household
4. If aged 15-17, have a guardian willing and able to provide informed consent to participate
5. If aged 15-17, be willing and able to provide informed assent to participate
6. If aged 18-24, be willing and able to provided informed consent to participate

Other vulnerable populations (OVP):
1. Be identified as a household with one or more OVP from the household screening
2. Must be 18 years of age or older
3. Randomly selected if there is more than one OVP in the household
4. Willing and able to provide informed consent to participate

Exclusion criteria: 1. Not identified as being among eligible groups
2. Outside of age range
3. Incapable of providing informed consent/assent

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
Infections and Infestations
HIV/AIDS

Intervention(s)

The Population Council, in collaboration with the University of Malawi College of Medicine, is conducting an evaluation of a USAID supported programme entitled “One Communality” that is being implemented in communities in the Southern region of Malawi. Residents living in areas where the One Community (OC) programme is being implemented are eligible to participate in the OC evaluation. The evaluation seeks to assess the extent of which the OC programme is effective in improving the wellbeing and decreasing the risk of HIV acquisition among three priority populations:
1. Orphans and vulnerable children (OVC)
2. Out-of-school adolescent girls and young women (AGYW)
3. Other vulnerable populations (OVP) this includes fisherfolk, estate workers, vendors etc.

To evaluate the OC programme, communities are randomly assigned to initiate the OC programme at different times over approximately three years. Some communities initiate the program immediately, some mid-way and some toward the end of the evaluation. A total of 24 communities are participating in the evaluation. Residents in the communities who are OVC, AGWY and OVP are eligible to participate in the OC programme and therefore are able to participate in this study, the evaluation. Interviews of OVC, AGWY and OVC are conducted by study trained enumerators and take place at their households at four times, once prior to the start of the OC programme and three additional times, approximately every 10 to 12 months. Interviews with eligible residents are conducted whether they participate in the OC programme or not, although it is expected a significant proportion do participate. Interviews take place immediately prior to each step where the OC programmes initiates in a new set of communities. Only a small number of eligible OVC, AGWY and OVP in any one community, at any one time, are randomly selected for interviews, thus, eligible participants are not likely to be interviewed more than once throughout the evaluation.

Primary Outcome(s)

1. Percent of school-aged children regularly attending school is measured using a survey interview at baseline and three follow up rounds, with 10-12 months between each round
2. Percent of caregivers who agree that harsh physical punishment is an appropriate means of discipline or control in the home is measured using a survey interview at baseline and three follow up rounds, with 10-12 months between each round
3. Percent of children too sick to participate in daily activities is measured using a survey interview at baseline and three follow up rounds, with 10-12 months between each round
4. Percent of caregivers who know their child’s status is measured using a survey interview at baseline and three follow up rounds, with 10-12 months between each round
5. Percent of HIV-negative participants who have obtained the results of an HIV test within the previous six months is measured using a survey interview at baseline and three follow up rounds, with 10-12 months between each round
6. Percent of participants reporting using a condom at last sex is measured using a survey interview at baseline and three follow up rounds, with 10-12 months between each round
7. Percent of participants reporting sexual behaviour with 2 or more partners in the previous 30 days is measured using a survey interview at baseline and three follow up rounds, with 10-12 months between each round
8. Percent of participants who hold positive norms regarding gender-based violence is measured using a survey interview at baseline and three follow up rounds, with 10-12 months between each round
9. Percent of participants who hold equitable norms regarding the roles of women and men is measured using a survey interview at baseline and three follow up rounds, with 10-12 months between each round

Secondary Outcome(s)

No secondary outcomes.

Secondary ID(s)

PC785

Source(s) of Monetary Support

United States Agency for International Development