Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cost-effectiveness Evaluation of Vector Control Strategies in Mozambique
Brief Summary: This study aims to provide National Malaria Control Programs (NMCP), international donors and other key stakeholders with clear evidence on the impact and cost-effectiveness of using indoor residual spraying (IRS) with a non-pyrethroid insecticide in a high malaria transmission area that has universal long-lasting insecticidal net (LLIN) coverage. This is an interventional study with IRS serving as the research intervention.

The district of Mopeia, in the province of Zambezia, Mozambique will be the study site. This is a high transmission area with a malaria parasite prevalence of 54% in children. The Ministry of Health distributed LLINs in Mopeia in 2014-2015.

The NMCP through funding from President's Malaria Initiative Africa Indoor Residual Spraying Project (PMI-AIRS) was able to cover half a district with indoor residual spraying. A simplified census took place in mid-2016 to determine the number of children five years of age and under in the district and enumerate and map the households to assist in implementation.

From the 115 villages/bairros existent in Mopeia, 86 clusters were randomized in a government randomization ceremony to either receive IRS with Actellic or maintain no IRS. The IRS was implemented through a partnership between the NMCP and PMI-AIRS according to standard operational and consent procedures. From each cluster, a cohort of 18 children five years of age and under will be followed monthly to assess malaria incidence at the community level in both IRS and non-IRS villages. There will be 774 children in the IRS villages and 774 children in the no-IRS villages (total cohort will be 1548). Additionally, the routine health centre reporting system will be strengthened to assess malaria incidence in children five years of age and under by passive case detection. Three cross sectional studies in April 2017, April 2018, and April 2019 will assess changes in net use, health seeking behaviour and malaria prevalence at the community level.

Entomological data will be collected from both IRS and non-IRS areas to assess the vector dynamics and insecticide resistance pattern of the local vector populations from sprayed and unsprayed areas. Data on the costs of the implementation as well as health-related expenditures at health system and household levels will be collected prospectively throughout the study. These costs will be determined using both health system and societal perspectives.

The incidence rate in IRS and no-IRS areas will be combined with the micro-costing data to calculate the cost per case averted at community and health facility level.

These findings will be disseminated to the NMCP and international donors and stakeholders to complement the World Health Organization (WHO) guidance on combining indoor residual spraying and long-lasting insecticidal nets.


Options:
A: Inclusion Criteria:

* Individuals who consent to participate in the study
* Residents in the study area
* Older than 6 months of age (or weighing more than 5Kg)
* Women in the second or third trimester who are not on IPTp

Exclusion Criteria:

* Individuals who do not consent to participate in the study
* Younger than 6 months of age (or weighing more than 5Kg)
* Women in the first trimester of pregnancy
* Severely ill individuals
* Individuals on contra-indicated medication
B: Inclusion Criteria:

* all consenting adults, assenting minors (12-18) and caregivers of children under 12

Exclusion Criteria:

* all infants 0-6 months of age
C: Household inclusion criteria:

* Households with residents at the time of survey
* Agreement of the adult resident to provide informed consent for the intervention and survey

Study subjects inclusion criteria:

* Passive case detection by health facilities will include all residents in the study clusters; active case detection will include residents of \>6 months
* Agreement of parent/guardian to provide informed consent and minors to provide assent.

Household exclusion criteria:

* Household vacant
* No adult resident home on more than 3 occasions

Study subjects exclusion criteria:

• Participants not home on day of survey
D: Inclusion Criteria:

1. Index Case Investigation Inclusion Criteria:

   * Malaria infection (either locally transmitted or imported) detected at a health facility via passive surveillance, and
   * Resides in a study Enumeration Area (EA), and
   * Provides informed consent
2. RACD Intervention Inclusion Criteria:

   * Provides informed consent, and
   * Index case resides in study EA, and
   * All non-index cases that reside or spent at least one night in the Target Area in the past 4 weeks, and
   * Residents of the six houses closest to the index case, and
   * If 25 people are not enrolled in the study at the first six houses, plus the index case household, after the second visit then additional houses can be approached on the third visit.
3. rfMDA Intervention Inclusion Criteria:

   * Provides informed consent, and
   * Index case resides in study EA, and
   * All non-index cases that reside or spent at least one night in the Target Area in the past 4 weeks, and
   * Residents of the six houses closest to the index case, and
   * If 25 people are not enrolled in the study at the first six houses, plus the index case household, after the second visit then additional houses can be approached on the third visit.
4. Artemether/Lumefantrine (A-L) (combination medication) Inclusion Criteria:

   * Consent to take A-L medication
   * Does not meet A-L Exclusion Criteria under item #4 below
5. Pill count Inclusion Criteria:

   * Provides consent, and
   * People who receive any number of RACD or rfMDA drug dose(s)
6. Reactive Vector Control Inclusion Criteria:

   * Informed consent provided by head of household or person in otherwise in charge of household, and
   * Index case resides in study EA, and
   * Index household and 6 non-index households closest to index household
7. Endline Survey, Individual, Inclusion Criteria:

   * Provides informed consent, and
   * Resides or spent at least 1 night in the EA in the preceding 4 weeks
8. Acceptability Assessment: Individual Interviews with study participants, Inclusion Criteria:

   * Provides informed consent, and
   * Resident of index household or of neighbouring households
9. Acceptability Assessment: Individual Interviews with key stakeholders, Inclusion Criteria:

   * In leadership position within Zambezi region, and
   * Provides informed consent
10. Acceptability Assessment: Individual Interview with refusers, Inclusion Criteria:

    * Refused to participate in rfMDA, RACD, and/or RAVC, and
    * Provides informed consent to take part in the anonymous survey
11. Acceptability Assessment: Focus group discussions with study participants, Inclusion Criteria:

    * Provides informed consent, and
    * Was eligible to be enrolled in the study in participant's Target Area, and
    * Either took part in RACD or rfMDA intervention (+/- RAVC), OR refused these interventions

Exclusion Criteria:

1. Index Case Investigation Exclusion Criteria:

   * Malaria infection identified through active case detection
   * Refusal to participate
2. RACD Intervention Exclusion Criteria:

   * Index case does not reside in study EA, or
   * Refusal to participate in RACD, or
   * Household received the intervention in the previous 5 weeks, or
   * Household \> 500 m from the index case, or
   * Severe or complicated malaria as assessed by study nurse (this will lead to referral for further evaluation at health facility but not enrolment in study)
3. rfMDA Intervention Exclusion Criteria:

   * Index case does not reside in study EA, or
   * Refusal to participate in rfMDA, or
   * Household received the intervention in the previous 5 weeks, or
   * Household \> 500 m from the index case, or
   * Severe or complicated malaria as assessed by study nurse (this will lead to referral for further evaluation at health facility but not enrolment in study)
4. Artemether/Lumefantrine (combination medication) Exclusion Criteria:

   * Pregnancy in first trimester, or
   * Previous regular menstruation, with no menstruation for most recent 4 weeks, or
   * Weight \< 5 kg\*, or
   * Severe malaria, or
   * Known allergy to A-L, or
   * Refusal of the offered A-L

     * Note regarding A-L weight exclusion: Because of the pre-set required field at the top of the Eligibility section of this Application, the investigators have indicated a 6 month minimum age limit, primarily to note to the reader that there will be a lower age limit to infants enrolled. Yet during the actual conduct of this trial the investigators will utilize 5 kg weight as the cutoff, rather than using age. A lower weight cutoff of 5 kg is in accordance with A-L's manufacturer (Novartis)'s guidance on supporting pediatric data.
5. Pill count Exclusion Criteria:

   * Refusal to participate in pill count, or
   * Individuals who did not receive any drug doses through RACD or rfMDA
6. Reactive Vector Control Exclusion Criteria:

   * Refusal by head of household to participate in RAVC, or
   * Already received RAVC during current transmission season, or
   * Household is \> 500 m from index case household (note: refusal to participate in RACD or rfMDA is not an exclusion criterion for RAVC)
7. Endline Survey, Individual, Exclusion Criteria:

   • Refusal to participate in Endline Survey (note: lack of participation in rfMDA or RACD is not an exclusion criterion)
8. Acceptability Assessment: Individual Interviews with study participants, Exclusion Criteria:

   * Refusal to participate in Acceptability Assessment, or
   * Speaks language not understood or able to be translated, or
   * Key stakeholder \[see below\]
   * Age \< 15 years
9. Acceptability Assessment: Individual Interviews with key stakeholders, Exclusion Criteria:

   * Refusal to participate in Acceptability Assessment, or
   * Speaks language not understood or able to be translated, or
   * Not in leadership position
10. Acceptability Assessment: Individual Interview with refusers, Exclusion Criteria:

    * Refusal to participate in Acceptability Assessment, or
    * Speaks language not understood or able to be translated, or
    * Age \< 15 years
11. Acceptability Assessment: Focus group discussions with study participants, Exclusion Criteria:

    * Refusal to participate in Acceptability Assessment, or
    * Speaks language not understood or able to be translated, or
    * Key stakeholder or in another leadership position, or
    * Age \< 15 years

Answer: B