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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03371914
Other study ID # INSaludPublica
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 12, 2017
Est. completion date December 1, 2019

Study information

Verified date August 2020
Source Instituto Nacional de Salud Publica, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date December 1, 2019
Est. primary completion date September 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Management training and data feedback
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.

Locations

Country Name City State
Nigeria Society for Family Health, Headquarters Abuja

Sponsors (3)

Lead Sponsor Collaborator
Instituto Nacional de Salud Publica, Mexico National Agency for the Control of AIDS (NACA), Society For Family Health (SFH)

Country where clinical trial is conducted

Nigeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Two years
Primary 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. Two years
Primary 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. Two years
Primary 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. Two years
Secondary 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. Two years
Secondary 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. Two years
Secondary 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. Two years
Secondary 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". Two years
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