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Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria

Primary Purpose

HIV/AIDS

Status
Terminated
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Management training and data feedback
Sponsored by
Instituto Nacional de Salud Publica, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring costing, behavioral intervention, management

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clusters: community-based organizations that serve female sex workers under Society for Family Health, through the SHIPs or Global Fund grants
  • Participants: managers ("officers") that oversee the functions of the organization and supervise volunteer staff

Exclusion Criteria:

  • Clusters: excludes organizations not serving female sex workers and not working under Society for Family Health, through Global Fund or SHIPs grants
  • Participants: excludes anyone not explicitly working as a manager overseeing volunteer implementation

Sites / Locations

  • Society for Family Health, Headquarters

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment: Management + data training

Control: data training only

Arm Description

The treatment group in the study will receive a 5-day training. The first two days of the training will consist of introducing the data collection tools and collecting baseline data. Days three through five of the training will consist of a variety of management topics. On a monthly basis, the treatment group will receive data visualizations that will compare their site's performance that month to pervious performance and to other sites in the study. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis.

The control group will receive only a 2-day training which will focus on data collection alone. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis.

Outcomes

Primary Outcome Measures

Change in cost per female sex worker reached by HIV education services
This measures the total cost of HIV education provision, divided by the number of female sex workers (FSWs) reached by the service.
Change in cost per female sex worker tested
This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested.
Change in cost per female sex worker treated for STIs (sexually transmitted infections)
This measures the total cost of STI treatment, divided by the number of FSWs treated for any STI.
Change in cost per female sex worker tested positive
This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested positive for HIV.

Secondary Outcome Measures

Productivity of HIV education
Productivity of the organizations will be measured as the number of outputs produced for the HIV education intervention-number of FSW reached by HIV education.
Productivity of HIV testing
Productivity of the organizations will be measured as the number of outputs produced for the HIV testing and counseling interventions-number of FSW tested for HIV.
Productivity of STI treatment
Productivity of the organizations will be measured as the number of outputs produced for the STI treatment intervention-number of FSW treated for STIs.
Job satisfaction
Measured through a composite score of five Likert scale questions about satisfaction, answers ranging from 1-5, 1 being "very dissatisfied" and 5 being "very satisfied".

Full Information

First Posted
September 16, 2017
Last Updated
August 3, 2020
Sponsor
Instituto Nacional de Salud Publica, Mexico
Collaborators
Society For Family Health (SFH), National Agency for the Control of AIDS (NACA)
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1. Study Identification

Unique Protocol Identification Number
NCT03371914
Brief Title
Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria
Official Title
Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to defunding of USAID project that supported the majority of the sites selected in the randomization.
Study Start Date
August 12, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Salud Publica, Mexico
Collaborators
Society For Family Health (SFH), National Agency for the Control of AIDS (NACA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study seeks to measure the costs associated with HIV prevention service delivery to female sex workers (FSW) in Nigeria, as well as examine the relationship between management practices at the community-based organizations (CBOs) and costs. To complete these goals, the study will collect both retrospective and prospective data from CBOs and from centralized information from study partners (Society for Family Health, SFH). In the prospective section of the study, CBOs will be sampled and assigned to either treatment or control groups. Data collected at the CBOs will be aggregated by the CBO managers, and those in the treatment group will receive feedback on their performance on a monthly basis. Those in the treatment group will additionally receive a management training to guide their management practices. Researchers hypothesize that there will be improvements in management indicators and therefore decreases in costs at CBOs in the treatment group. Results will be disseminated to local, national, and international stakeholders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
costing, behavioral intervention, management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment: Management + data training
Arm Type
Experimental
Arm Description
The treatment group in the study will receive a 5-day training. The first two days of the training will consist of introducing the data collection tools and collecting baseline data. Days three through five of the training will consist of a variety of management topics. On a monthly basis, the treatment group will receive data visualizations that will compare their site's performance that month to pervious performance and to other sites in the study. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis.
Arm Title
Control: data training only
Arm Type
No Intervention
Arm Description
The control group will receive only a 2-day training which will focus on data collection alone. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis.
Intervention Type
Behavioral
Intervention Name(s)
Management training and data feedback
Intervention Description
The management training will consist of a variety of management topics, such as financial, workplace and staff management. The training will include a number of tools that the managers will be expected to bring back with them and use regularly at their site. There will be monthly refresher trainings for the managers via an online platform, where participants will interact about the topics covered in the training and others relevant to their work as managers. Participants will also receive monthly visualizations that compare the data that they enter via tablet monthly to both (1) their baseline data, and (2) to other sites' data. Outcomes that will be measured and reported back to sites include cost per client tested, number of condoms distributed, and number of FSW reached by educational interventions.
Primary Outcome Measure Information:
Title
Change in cost per female sex worker reached by HIV education services
Description
This measures the total cost of HIV education provision, divided by the number of female sex workers (FSWs) reached by the service.
Time Frame
Two years
Title
Change in cost per female sex worker tested
Description
This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested.
Time Frame
Two years
Title
Change in cost per female sex worker treated for STIs (sexually transmitted infections)
Description
This measures the total cost of STI treatment, divided by the number of FSWs treated for any STI.
Time Frame
Two years
Title
Change in cost per female sex worker tested positive
Description
This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested positive for HIV.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Productivity of HIV education
Description
Productivity of the organizations will be measured as the number of outputs produced for the HIV education intervention-number of FSW reached by HIV education.
Time Frame
Two years
Title
Productivity of HIV testing
Description
Productivity of the organizations will be measured as the number of outputs produced for the HIV testing and counseling interventions-number of FSW tested for HIV.
Time Frame
Two years
Title
Productivity of STI treatment
Description
Productivity of the organizations will be measured as the number of outputs produced for the STI treatment intervention-number of FSW treated for STIs.
Time Frame
Two years
Title
Job satisfaction
Description
Measured through a composite score of five Likert scale questions about satisfaction, answers ranging from 1-5, 1 being "very dissatisfied" and 5 being "very satisfied".
Time Frame
Two years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clusters: community-based organizations that serve female sex workers under Society for Family Health, through the SHIPs or Global Fund grants Participants: managers ("officers") that oversee the functions of the organization and supervise volunteer staff Exclusion Criteria: Clusters: excludes organizations not serving female sex workers and not working under Society for Family Health, through Global Fund or SHIPs grants Participants: excludes anyone not explicitly working as a manager overseeing volunteer implementation
Facility Information:
Facility Name
Society for Family Health, Headquarters
City
Abuja
Country
Nigeria

12. IPD Sharing Statement

Citations:
PubMed Identifier
30386184
Citation
Bautista-Arredondo S, Nance N, Salas-Ortiz A, Akeju D, Oluwayinka AG, Ezirim I, Anenih J, Chima C, Amanze O, Omoregie G, Ogungbemi K, Aliyu SH. The role of management on costs and efficiency in HIV prevention interventions for female sex workers in Nigeria: a cluster-randomized control trial. Cost Eff Resour Alloc. 2018 Oct 23;16:37. doi: 10.1186/s12962-018-0107-x. eCollection 2018.
Results Reference
derived

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Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria

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