A scaled up structural intervention program versus current national HIV prevention program

• Register: ISRCTN
• Last refreshed on: 30 January 2023
• Main ID: ISRCTN54878784
• Date of registration: 11/06/2013
• Prospective Registration: Yes
• Primary sponsor: The Autonomous University of Guerrero (Universidad Autónoma de Guerrero) (Mexico)
• Public title: A scaled up structural intervention program versus current national HIV prevention program
• Scientific title: Inter-ministerial National Structural Intervention Trial: a stepped wedge trial of HIV prevention in Botswana
• Date of first enrolment: 01/08/2013
• Target sample size: 300000
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN54878784
• Study type: Interventional
• Study design: Stepped-wedge cluster randomised controlled trial, district as unit of allocation, intervention and analysis (Prevention)
• Phase: Not Applicable

Countries of recruitment

Botswana, Mexico

Contacts

• Name: Neil Andersson

Key inclusion & exclusion criteria

Inclusion criteria:
For intervention:
All districts will be eligible for randomization to receive the intervention. In each intervention district, all residents aged 15 and above will be eligible. Different intervention activities will address different groups of the population, who will be free to decide whether to take up the offer:
1. Economic empowerment including skills workshop and government structural support offered to women aged 18-24, especially those not in school or employment.
2. Audio-drama discussion groups will be offered to all ages and both sexes
3. Concerting of service provision will include discussions with all local service-providers (all eligible)

For impact surveys: Young women and young men aged 15-29 years in 10 clusters (random selection of enumeration areas from the recent census) in each of five intervention and five non-intervention districts.

Exclusion criteria:
For intervention: No district will be excluded. Within each intervention district, people not resident in the district will be excluded to minimize contamination (by people in other districts hearing of the interventions and wishing to take advantage of them, thus diluting the measured impact).

For impact surveys: Field workers will not interview or take blood samples from anyone they judge to be unable to give informed consent or to understand the survey questions.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

HIV prevention
Infections and Infestations
Unspecified human immunodeficiency virus [HIV] disease

Intervention(s)

30 districts randomly assigned to intervention groups, stratified by development status and HIV prevalence.

The structural intervention: Activities focus on empowerment of women aged 15-29 years, concerting existing local health, social and other services in favor of the most vulnerable, especially young women, and developing an enabling environment using an audio-drama to stimulate community-wide discussion about gender violence and HIV risk.

Primary Outcome(s)

HIV sero-prevalence among women aged 15-29 years. Outcome measured on completion of the intervention in year 4 and compared with the baseline of the second group of communities

Secondary Outcome(s)

Protective knowledge, attitudes, subjective norms, intention to change, agency, discussion of prevention, behaviours related to gender violence and HIV risk and prevention

Secondary ID(s)

CIET CD2-INSTRUCT

Source(s) of Monetary Support

Government of Botswana (Botswana)

Ethics review

Status:
Approval date:
Contact:

Not provided at the time of registration

Results

• Results available: Yes
• Date Completed: 31/07/2018