Clinical trial NCT04160169: Counseling on Injectable Contraception and HIV Risk in Tanzania
Official title: Counseling on Injectable Contraception and HIV Risk: Evaluation of a Pilot Intervention in Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Counseling
Tanzania
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Ministry of Health, Tanzania
name: Johns Hopkins Bloomberg School of Public Health
First posted: 2019-11-12
Enrollment: 10
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women attending a participating healthcare facility during the three month intervention period and who met eligibility criteria received the hormonal contraception and HIV risk messages.

Brief summary: The main objective of the evaluation was to assess the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and behavior during a three month pilot intervention in ten healthcare facilities in Tanzania.

Detailed description: The evaluation assessed the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and uptake during a three month pilot intervention. The intervention was conducted September-November 2018 in ten healthcare facilities located in the Iringa and Njombe regions of Tanzania. Data collection for the evaluation occurred November-December 2018 and included 471 client exit interviews, 26 healthcare provider interviews, and the extraction of monthly aggregate service statistics for 12 months prior to the intervention and three months of the intervention. Univariate and bivariate analyses were used to assess quantitative interview data. Thematic qualitative assessment was used to assess qualitative interview data from healthcare providers. Interrupted time series analysis was used to assess changes in the trend of monthly contraceptive uptake.

Eligibility criteria: Inclusion Criteria:

* Expressed interest in injectable use
* HIV-negative or unknown HIV status

Exclusion Criteria:

* Positive HIV status known to healthcare provider

Primary outcomes:
measure: Number of clients obtaining an injectable during their family planning appointment
timeFrame: After implementation of counseling messages, up to 13 weeks
measure: Percent of clients obtaining an injectable during their family planning appointment
timeFrame: After implementation of counseling messages, up to 13 weeks
measure: Monthly total number of family planning clients by method obtained
timeFrame: September 2017 through November 2018
Secondary outcomes:
measure: Number of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall
timeFrame: After implementation of counseling messages, up to 13 weeks
measure: Percent of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall
timeFrame: After implementation of counseling messages, up to 13 weeks
measure: Number of correct True/False statements on hormonal contraception and HIV (11 total)
timeFrame: After implementation of counseling messages, up to 13 weeks
measure: Percent of correct True/False statements on hormonal contraception and HIV (11 total)
timeFrame: After implementation of counseling messages, up to 13 weeks
measure: Number of interviewed clients reporting an intention to use condoms as a dual method
timeFrame: After implementation of counseling messages, up to 13 weeks
measure: Percent of interviewed clients reporting an intention to use condoms as a dual method
timeFrame: After implementation of counseling messages, up to 13 weeks
Other outcomes:
Locations:
city: Ilula
country: Tanzania
facility: Ilula Hospital
state: Iringa
city: Mafinga
country: Tanzania
facility: Mafinga Hospital
state: Iringa
city: Iringa
country: Tanzania
facility: Ihongole Health Center
city: Iringa
country: Tanzania
facility: Ipogolo Health Center
city: Iringa
country: Tanzania
facility: Kimande Health Center
city: Njombe
country: Tanzania
facility: Ipelele Health Center
city: Njombe
country: Tanzania
facility: Kibena Regional Referral Hospital
city: Njombe
country: Tanzania
facility: Makambako Hospital
city: Njombe
country: Tanzania
facility: Makete Hospital
city: Njombe
country: Tanzania
facility: Njombe Health Center
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Janine Barden-O'Fallon, PhD
role: PRINCIPAL_INVESTIGATOR
References: