Clinical trial NCT05774626: Injectable Contraception Cohort Study in Punjab, Pakistan
Official title: Continuation of Subcutaneous and Intramuscular Injectable Contraception: a Non-randomized Prospective Cohort Study in Punjab, Pakistan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Contraceptive Usage
Keywords: injectable contraception
prospective cohort study
Pakistan
Lead sponsor: Jhpiego
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clients receiving family planning counseling and services at participating public and private health facilities in Kasur and Khanewal districts of Punjab, Pakistan

Brief summary: The aim of this study is to assess the value proposition of expanding contraceptive options available to women in Punjab, Pakistan to include subcutaneous depot medroxyprogesterone acetate (DMPA-SC).

Specific objectives are:

1. To compare 12-month continuation rates for DMPA-SC and intramuscular DMPA (DMPA-IM) among married women 18- 49 years of age in two districts of Punjab, Pakistan
2. To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
3. To assess how well women opting for self-injection of DMPA-SC adhere to standards for commodity storage, injection timing, injection technique, and waste disposal

Detailed description: Depot medroxyprogesterone acetate (DMPA) is a highly-effective, injectable contraceptive method that requires injections every 11 to 17 weeks. It is available in both intramuscular (IM) and subcutaneous (SC) formulations, which are therapeutically equivalent and have similar safety profiles. DMPA-IM has been included in the method mix for most countries for many years. DMPA-SC is a newer formulation being added to the method mix in select settings. Studies demonstrate that self-administration of subcutaneous DMPA (DMPA-SC) outside clinical settings is safe, effective, feasible, acceptable, and can improve continuation, and a recommendation in favor of self-injected DMPA-SC is included in WHO guidelines on self-care interventions for health and well-being.

The Bill and Melinda Gates Foundation is funding implementation research in multiple countries to understand how self-injection of DMPA-SC can best be introduced to specific markets to expand the contraceptive options available to women and girls, health system characteristics, the demand for self-injection when DMPA-SC is offered alongside a range of other methods, and women's and girl's ability to start and continue use. Jhpiego has received funding to conduct one of these 'market tests' in Punjab, Pakistan.

The aim of this study is to assess the value proposition of expanding contraceptive options available to women in Punjab, Pakistan to include subcutaneous depot medroxyprogesterone acetate (DMPA-SC).

Specific objectives are:

1. To compare 12-month continuation rates for DMPA-SC and intramuscular DMPA (DMPA-IM) among married women 18- 49 years of age in two districts of Punjab, Pakistan
2. To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
3. To assess how well women opting for self-injection of DMPA-SC adhere to standards for commodity storage, injection timing, injection technique, and waste disposal

Eligibility criteria: Inclusion Criteria:

* Married women aged 18-49 years
* Decide to use injectable contraception and meet WHO medical eligibility criteria for injectable use
* Want to avoid pregnancy for at least 12 months
* Live within study districts
* Are willing to be contacted by study team members via telephone and/or in-person

Exclusion Criteria:

* Women under age 18 and above 49
* Unmarried women
* Hope to become pregnant within next 12 months
* Do not reside within study districts
* Are not willing to be contacted by study team members via telephone or in-person
* Lack cognitive capacity to give informed consent or complete interviews

Primary outcomes:
measure: DMPA continuation rate
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
measure: Characteristics of women in the two study groups (DMPA-SC and DMPA-IM users)
timeFrame: At enrollment
measure: Family planning service provision and injectable contraceptive use experiences of women in the two study groups (DMPA-SC and DMPA-IM users)
timeFrame: Up to 12 months
Locations:
city: Khanewal
country: Pakistan
facility: Bhu 76/10-R
state: Pubjab
city: Kasur
country: Pakistan
facility: BHU Fatehpur
state: Punjab
city: Kasur
country: Pakistan
facility: BHU Herdo Sehari
state: Punjab
city: Kasur
country: Pakistan
facility: BHU Pakhoki
state: Punjab
city: Kasur
country: Pakistan
facility: BHU Rao Khan Wala
state: Punjab
city: Kasur
country: Pakistan
facility: BHU Serhali
state: Punjab
city: Kasur
country: Pakistan
facility: BHU Sheikh Bhago
state: Punjab
city: Kasur
country: Pakistan
facility: Fatima Maternity Home
state: Punjab
city: Kasur
country: Pakistan
facility: FHC Kasur
state: Punjab
city: Kasur
country: Pakistan
facility: FWC Chunian-1
state: Punjab
city: Kasur
country: Pakistan
facility: FWC Kasur 5
state: Punjab
city: Kasur
country: Pakistan
facility: FWC Kotha Kalan
state: Punjab
city: Kasur
country: Pakistan
facility: FWC Qaiser Garh
state: Punjab
city: Kasur
country: Pakistan
facility: FWC Rosa Tibba
state: Punjab
city: Kasur
country: Pakistan
facility: FWC Sheikh Umad Kohna
state: Punjab
city: Kasur
country: Pakistan
facility: FWC Talwandi
state: Punjab
city: Kasur
country: Pakistan
facility: Hajra Maternity Home
state: Punjab
city: Kasur
country: Pakistan
facility: Rafique Maternity Home
state: Punjab
city: Kasur
country: Pakistan
facility: RHC Changamanga
state: Punjab
city: Kasur
country: Pakistan
facility: RHC Ellabad
state: Punjab
city: Kasur
country: Pakistan
facility: RHC Gandasingh
state: Punjab
city: Kasur
country: Pakistan
facility: RHC Khuddian
state: Punjab
city: Kasur
country: Pakistan
facility: RHC Mustafabad
state: Punjab
city: Khanewal
country: Pakistan
facility: Ali Maternity Home
state: Punjab
city: Khanewal
country: Pakistan
facility: Bhu 171/10-R
state: Punjab
city: Khanewal
country: Pakistan
facility: Bhu 30/10-R
state: Punjab
city: Khanewal
country: Pakistan
facility: Bhu 44/15-L
state: Punjab
city: Khanewal
country: Pakistan
facility: Bhu 79/10-R
state: Punjab
city: Khanewal
country: Pakistan
facility: Bhu 92/10-R
state: Punjab
city: Khanewal
country: Pakistan
facility: Bhu 92/15-L
state: Punjab
city: Khanewal
country: Pakistan
facility: BHU Chack 131/15 L
state: Punjab
city: Khanewal
country: Pakistan
facility: FHC DHQ Khanewal
state: Punjab
city: Khanewal
country: Pakistan
facility: FHC THQ Mian Cahnu
state: Punjab
city: Khanewal
country: Pakistan
facility: FWC Kacha Khuh
state: Punjab
city: Khanewal
country: Pakistan
facility: FWC Makhdoom Pur
state: Punjab
city: Khanewal
country: Pakistan
facility: FWC Model Center
state: Punjab
city: Khanewal
country: Pakistan
facility: RHC Kacha Khuh
state: Punjab
city: Khanewal
country: Pakistan
facility: RHC Makhdom pur
state: Punjab
city: Khanewal
country: Pakistan
facility: RHC Tulamba
state: Punjab
city: Khanewal
country: Pakistan
facility: Tehseen Surgical Clinic
state: Punjab
city: Khanewal
country: Pakistan
facility: Zainab Maternity Home
state: Punjab
Study officials:
affiliation: Jhpiego
name: Hannah Tappis, DrPH
role: PRINCIPAL_INVESTIGATOR
References: